Lucknow, Uttar Pradesh, India
Not disclosed
On-site
Full Time
Below are the roles & responsibilities: The Sr. Executive – Sales (GIR) will be responsible for carrying out sales function & activities in the assigned territory. Based in the designated location for GI & Respiratory products and will be responsible of the complete designated territory. • Ensure Customer call & coverage across the territory individually and along with his direct team members. • Handling Distributor’s sale & marketing activity. • Regularly Conducting live GI&R products demo. • Ensure implementation of marketing plan in territory and conducting market development activities. • Gathering market, competition, key customer data through his team members • Weekly Reporting of all the sales activities on SFDC. • Regular discussion and engagement of customers for increase of installation base with the help of using right tools. • Maintain PCL accuracy and strong pipeline of leads. • Develop and Manage KOL’s. • Negotiating contracts • Meeting both the business and scientific needs of healthcare professionals • Attending and organizing trade exhibitions, conferences and meetings • Managing budgets Educational Qualification & Experience • Should be minimum graduate or above in science stream • Should have minimum working experience of 5-7 years in medical equipment/capital equipment/surgical industry. Others • Should have basic knowledge in Excel, Word, Powerpoint. • Should be open to travel extensively Interested candidates, please share your resume to taru.arora@olympus.com. Regards HR Team Show more Show less
Ahmedabad, Gujarat, India
Not disclosed
On-site
Full Time
Below are the roles & responsibilities: Executive/Senior -Sales (GS+URO+GYN) will be responsible for carrying out sales function & activity functions in the designated territory. He will be primarily responsible for generating leads and achieving sales targets for the Surgical products in his/her region. Generate enquiries/Leads for Company’s product line. Ensure Customer call & coverage across the designated territory for self as per organization policy. Organizing appointments and meetings with community- and hospital-based healthcare staff identifying and establishing new business. Demonstrating or presenting products to healthcare staff including doctors, nurses and pharmacists undertaking relevant research. Conduct in-depth presentations and product demonstrations to healthcare professionals, highlighting the clinical benefits and value proposition of our offerings. Handling Distributor’s effectively for sale & coverage. Manage and nurture a pipeline of opportunities, effectively moving them through the sales process. Develop and Manage HCP’s. Collaborate effectively with internal teams, including marketing, FSE, regulatory, and customer support, to ensure seamless customer experience. Keep close track of competitor activity and inform the management on a timely basis. Networking at the right levels to keep track of development / growth / new projects coming up in the region. Identify opportunities in Govt Tenders and work towards participating in the same to get business for the company. Sales forecasts on a monthly, quarterly and Annual basis so as to achieve budgets. Maintaining accurate records of customer interactions and sales activities; generate timely reports for management review. Representing the company at medical conferences, trade shows, and workshops to showcase products. Negotiating and closing the deal with customers. Meeting both the business and scientific needs of healthcare professionals Managing budgets Qualification & Experience Should be minimum graduate or above in science stream Should be well versed with MS-Word, Excel, PowerPoint. Should have minimum working experience of 5-7 years in the medical equipment/surgical industry. Others Negotiation skills Should be open to travel extensively Maintains professional image that reflects positively on the Company Excellent communication, negotiation, and relationship-building skills. Interested candidates, please mail your resume to taru.arora@olympus.com. Regards HR Team Show more Show less
Hyderabad, Telangana, India
Not disclosed
On-site
Full Time
About the Company: Olympus Corporation is a globally renowned leader in endoscopy enabled healthcare, pioneering innovative solutions that enhance people's lives every day. With a rich history spanning nearly a century, Olympus has continuously pushed the boundaries of what's possible in the realms of medical, scientific, and imaging technology. Since its inception, Olympus has remained committed to its founding principles of integrity, innovation, and quality. Over the years, the company has diversified its portfolio, excelling in various fields including endoscopy, microscopy, life sciences, and digital imaging. Purpose of the Role: The Senior Manager will act as the head of mechanical engineering R&D and the business process owner for Olympus’s Standard Operating Procedures related to product development, and function as a steward of our mechanical development processes. The ideal candidate will be a hands-on technical leader with extensive experience in developing mechanical components and systems for medical devices. This individual will be responsible for setting up the mechanical engineering R&D function for the global scope of work and owning the execution of engineering projects, ensuring alignment with Olympus’ global R&D strategy. The role is responsible for driving the R&D operations for India, focusing on leading mechanical engineering teams and project delivery in collaboration with the global R&D and India leaders. The incumbent will spearhead project planning, budget management, and technical oversight, ensuring seamless coordination across teams to meet project timelines and deliverables with minimal operational input from Olympus HQ. On the technical front, this role will provide strategic oversight while ensuring high-quality engineering outcomes in the development of medical devices. By leading mechanical engineering initiatives, this individual will guide the design, analysis, prototyping, verification, and validation processes, ensuring compliance with regulatory standards such as FDA Design Controls and ISO requirements. The position demands a strong mix of technical proficiency and proactive project leadership, fostering a collaborative environment that aligns mechanical R&D performance with Olympus’ offshore vision. Key Responsibilities: Functional Setup: Lead the functional setup and management of the mechanical engineering function, optimizing workflows, task assignments, hiring/team set-up, and resource management Identify and implement cutting-edge technologies and mechanical engineering practices, such as advanced simulation (FEA/CFD), material optimization, and additive manufacturing to improve product performance and drive innovation Hands on experience in designing and developing mechanical components in systems for manufacturing Seek to ideate enhancements to mechanical engineering processes, CAD tools, and methodologies, aiming to increase product development efficiency, communication, and quality Collaborate with global Project managers teams to ensure the engineering R&D function growth roadmap is aligned with Olympus’ long-term R&D strategy and technical priorities Develop and oversee technical training and knowledge-sharing programs for internal teams, fostering continuous skill development and alignment with Olympus’ technical standards Implement continuous improvement initiatives within the mechanical engineering function, driving technical process enhancements and increasing the efficiency and quality of product development across teams Work closely with the PMO to manage demand planning and resource forecasting for the function, ensuring sufficient talent and infrastructure for current and future mechanical engineering projects Participate in strategic planning and provide technical insights to support long-term growth and competitiveness Recruit staff, develop them through assignments, guidance, and mentorship, and manage their performance Create systems to ensure all updates/changes are communicated across sites/employees NPD and Stakeholder Management: Head the mechanical engineering function to own and account for the delivery, execution, and management of all NPD activities within the India scope of mechanical engineering Provide strategic oversight and guidance for mechanical R&D projects, ensuring external and internal teams align with performance specifications, regulatory standards, and Olympus’ overall R&D objectives Collaborate with Olympus PMO teams to develop and monitor technical roadmaps, ensuring smooth execution of project goals and resource allocations Act as the subject matter expert on mechanical design controls, providing guidance to product development teams (both internal and external) Ensure that mechanical design solutions meet performance, cost, manufacturability, and safety requirements through effective review and communication with global stakeholders Drive the development of IP strategies by working with PMO and legal teams, ensuring vendor partners adhere to Olympus’ requirements for protecting intellectual property in product designs Facilitate technical problem-solving by coordinating with global leads, ensuring swift resolution of challenges and minimizing project delays Project Management: Head the Mechanical Engineering R&D function to serve as the strategic interface between global PMO and vendor partners, providing updates on technical progress, risks, and issues while ensuring alignment with the overall R&D strategy Develop and manage technical roadmaps with input from vendor partners, ensuring timelines, milestones, and resource planning are optimized for the mechanical engineering function Regularly report project status to PMO leads and Olympus global teams, ensuring visibility of key technical achievements and roadblocks, and adjusting strategies as needed Manage and oversee the maintenance of technical RAID logs, working with vendor partners to ensure risks are identified, escalated, and addressed promptly Oversee coordination between vendor partners and software development teams to ensure seamless integration of mechanical designs into broader product architectures Ensure adherence to Olympus’ design control procedures and drive continuous improvements in these processes to enhance clarity, compliance, and usability Provide high-level guidance on prototyping, verification, and validation testing strategies, ensuring they meet Olympus’ quality and performance specifications Regulatory & Compliance: Ensure that all product development activities meet regulatory and industry standards, including FDA, CE, ISO, and other relevant certifications Act as the point of escalation for technical and regulatory compliance matters, ensuring external and internal teams engage with safety certification bodies and comply with applicable standards Maintain documentation in compliance with Good Manufacturing Practices (GMP) and quality system regulations Risk Management & Problem-Solving: Identify potential technical risks and implement mitigation strategies Provide technical guidance in solving engineering challenges during the product development lifecycle Person Specification: Education A degree or higher qualification in Mechanical Engineering, Biomedical Engineering, or related fields from a recognized university. A master's in mechanical engineering will be an added advantage. Experience 14+ years of overall experience in mechanical engineering or medical device development with 10+ years in medical devices domain 5+ years of experience with a medical devices company in a leadership role 9+ years of experience in mechanical design, prototyping, materials selection, and product development Strong understanding of medical device regulations (ISO 13485, FDA 21 CFR Part 820, etc.) Proven track record of leading teams in the design and development of Class II/III medical devices Skills Strong technical background in mechanical engineering, with experience in Medical Device development and/or sustaining engineering efforts Expertise in managing R&D engineering projects, including performance tracking, SLA/KPI definition, contract negotiation, and demand planning Proven ability to work through medical device product lifecycle management, including FDA Design Controls and international standards (e.g., 820-CFR, ISO14971, IEC60601), ensuring alignment with strategic roadmaps Experience in Project and Program Management, with a focus on vendor partner management, continuous improvement, and talent growth Familiarity with CAD tools and simulation tools, ensuring cross-functional collaboration to achieve business objectives Capable of developing deliverables to document mechanical designs for high-volume manufacturing and quality compliance Proficiency in working with PLM (Product Lifecycle Management) systems and conducting risk analyses and DFMEAs Excellent stakeholder management skills across PMO leads and vendor partners, ensuring timely project delivery and alignment with strategic goals Experience managing large data sets, financial analysis, and P&L ownership, utilizing these insights to drive process improvements and operational efficiencies Effective communication skills, both verbal and written, with the ability to present information clearly to cross-functional teams, vendor partners, and leadership Strong project management skills, with the ability to manage multiple projects simultaneously Excellent communication, leadership, and problem-solving skills Show more Show less
Hyderabad, Telangana, India
Not disclosed
On-site
Full Time
About Olympus Olympus Medical Systems India Private Limited commenced its business operation in Indian market on April 1, 2010. Olympus Medical Systems India is a wholly owned subsidiary of Olympus Corporation. Taking a plunge into the Indian market, team at Olympus wants to be the most respected reliable and chosen brand in health care domain. Olympus established its direct presence to build a very strong marketing and service facilities. With better and innovative technology, Olympus looks forward to grow its foothold into the market with the growth in Indian Economy. Business Overview Olympus Medical Systems India has a wide portfolio of products that are equipped with the latest innovative and superior technology. Olympus deals primarily in three verticals i.e. Gastrointestinal, Respiration & Surgical divisions and contribute to the medical society with state-of-the-art product categories that includes, Video Endoscopy, Endoscopic Ultrasound, Bronchoscopy, Endotherapy devices in Gastrointestinal & Respiratory range whereas Surgical division includes High-definition imaging system and Energy products to deal with Laparoscopy, General Surgery, Gynaecology and Urology field. Role Overview The HR Business Partner will be responsible for managing talent acquisition efforts to source and recruit top talent for the R&D Offshore Development Centre, ensuring a seamless hiring process aligned with business needs. The role will also involve coordinating HR operations, implementing engagement initiatives, and supporting organizational efforts in employee training and development. This position will act as a key liaison between the Hyderabad R&D team and the core HR team at the OMSI Head office & Global R&D HRBP to ensure alignment with strategic HR priorities. Illustrative Responsibilities 1.Talent Acquisition- •Manage full-cycle recruitment for the R&D center, including sourcing, screening, interviewing, and onboarding. •Preparing & updating job descriptions based on the discussions with the hiring managers. •Develop recruitment strategies to attract top technical talent for niche roles. • Develop effective relationships within the organization and the hiring community to have influence and impact the recruiting process and hiring. 2. Stakeholder & Business Partnership •Collaborate with R&D leadership to understand workforce needs and align HR strategies accordingly. •Act as a trusted HR advisor to managers and employees at the Hyderabad R&D center. 3.HR Operations •Oversee employee life cycle processes, including onboarding, transfers, and exits. •Ensure compliance with HR policies, processes, and documentation. •Maintain accurate and updated employee records. 4.Employee Engagement & Development •Implement engagement initiatives, recognition programs, and welfare activities. •Support managers in conducting performance appraisals and development discussions. •Collaborate with the core HR team at the Head Office on key HR initiatives and process improvements. 5. HR Analytics & Database •The person is also responsible to collect, compile, and analyze HR data, metrics, and statistics, and apply this data to make recommendations related to recruitment, attrition, engagement etc. •Updating Organization Chart on monthly basis. •Perform other duties as assigned. Minimum requirements Qualification – MBA in HR or equivalent degree. Preferred Experience – •Minimum 12-15 years of proven working experience as HR Business Partner, with strong focus on Talent Acquisition. •Proven experience in managing end-to-end recruitment processes, preferably for technical and R&D roles •MS Office (Excel & powerpoint) •Fluent in oral/written communication (English) •People oriented & result driven •Ability to work independently and collaboratively in a fast-paced, dynamic environment •Confidentiality & work ethics. Competencies •Strategic Mindset- Seeing ahead to future possibilities and translating them into breakthrough strategies. •Decision Quality- Making good and timely decisions that keep the organization moving forward. •Customer Focus- Building strong customer relationships and delivering customer-centric solutions. •Action Oriented- Taking on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm. •Ensures Accountability- Holding self and others accountable to meet commitments. •Drives Engagement- Creating a climate where people are motivated to do their best to help the organization achieve its objectives. •Develops Talent- Developing people to meet both their career goals and the organization’s goals. •Situational Adaptability- Adapting approach and demeanour in real time to match the shifting demands of different situations. •Demonstrates Self-Awareness- Using a combination of feedback and reflection to gain productive insight into personal strengths and weaknesses. Show more Show less
Hyderabad, Telangana, India
Not disclosed
Remote
Full Time
About the Company: Olympus Corporation is a globally renowned leader in endoscopy enabled healthcare, pioneering innovative solutions that enhance people's lives every day. With a rich history spanning nearly a century, Olympus has continuously pushed the boundaries of what's possible in the realms of medical, scientific, and imaging technology. Since its inception, Olympus has remained committed to its founding principles of integrity, innovation, and quality. Over the years, the company has diversified its portfolio, excelling in various fields including endoscopy, microscopy, life sciences, and digital imaging Purpose of the Role: The Sr Manager, India will act as the head of digital engineering R&D and the business process owner for Olympus’s Standard Operating Procedures related to digital product development (e.g., Digital Systems Design, Cloud Architecture, Data Engineering, AI/ML Development, Software Integration, etc.), and function as a steward of our digital engineering processes. The ideal candidate will be a strategic thinker with a deep understanding of digital technologies and a proven track record of managing high-performing teams in a global environment. The ideal candidate will be a hands-on technical leader with extensive experience in digital systems development for medical devices or related industries. This individual will be responsible for setting up the Digital Unit engineering R&D function for the global scope of work and owning the execution of digital engineering projects, ensuring alignment with Olympus’ global R&D strategy. The role is responsible for driving the R&D Digital Unit engineering teams operations for India, focusing on leading digital engineering teams and project delivery in collaboration with the global leadership and India leadership teams. The incumbent will spearhead project planning, budget management, and technical oversight, ensuring seamless coordination across teams to meet project timelines and deliverables with minimal operational input from Olympus HQ. On the technical front, this role will provide strategic oversight while ensuring high-quality engineering outcomes in the development of digital systems and software. By leading digital engineering initiatives, this individual will guide the design, development, integration, and validation processes, ensuring compliance with regulatory standards such as FDA Design Controls, ISO, and IEC standards. The position demands a strong mix of technical proficiency and proactive project leadership, fostering a collaborative environment that aligns digital R&D performance with Olympus’ offshore vision. Key Responsibilities: The role is reporting to the Global Head of Digital Unit, the senior management representative and ambassador of the Digital Unit at the respective regional Hub lead The R&D India Head of Digital Unit will further develop the delivery scope and technology focus of the hub in alignment with global functions, with the aim of driving innovation, improving operational efficiency, building up capabilities, and enhancing both patient and customer experiences The role is intended to deliver a global “multiplier effect” by driving collaboration and coordination across the DU functions as well as in the region Functional Setup: Lead the functional setup and management of the digital engineering function, optimizing workflows, task assignments, hiring/team set-up, and resource management Ideate and implement enhancements to digital engineering processes and tools, aiming to increase product development efficiency, communication, and quality Collaborate with global DU R&D teams to ensure the digital engineering R&D function growth roadmap is aligned with Olympus’ long-term R&D strategy and technical priorities Develop and oversee technical training and knowledge-sharing programs for internal teams, fostering continuous skill development and alignment with Olympus’ digital standards Work closely with the global DU to manage demand planning and resource forecasting for the function, ensuring sufficient talent and infrastructure for current and future digital engineering projects Identify and implement cutting-edge technologies and digital engineering practices, such as cloud computing, data engineering, artificial intelligence (AI), and machine learning (ML) to improve product performance and drive innovation NPD and Stakeholder Management: Head the digital engineering function to own and account for the delivery, execution, and management of all NPD activities within the India scope of digital engineering Define and execute the digital strategy for medical devices in alignment with global Digital Strategy, focusing on software development, data analytics, cloud solutions, connectivity, and user experience Oversee the design and development of digital systems that enhance device functionality, data security, and remote monitoring capabilities Collaborate with Olympus DU R&D teams to develop and monitor technical roadmaps, ensuring smooth execution of project goals and resource allocations Ensure that digital engineering solutions meet performance, cost, scalability, and security requirements through effective review and communication with global stakeholders Solving by coordinating with global leads, ensuring swift resolution of challenges and minimizing project delays Drive innovation by identifying and implementing emerging technologies such as artificial intelligence (AI), machine learning (ML), and advanced data analytics into medical device systems Project Management: Head the India Digital Engineering R&D function to serve providing updates on technical progress, risks, and issues while ensuring alignment with the overall R&D strategy Develop and manage technical roadmaps with input from vendor partners, ensuring timelines, milestones, and resource planning are optimized for the digital engineering function Regularly report project status to Olympus global teams, ensuring visibility of key technical achievements and roadblocks, and adjusting strategies as needed Ensure adherence to Olympus’ digital system design control procedures and drive continuous improvements in these processes to enhance clarity, compliance, and usability Provide high-level guidance on digital system validation and testing strategies, ensuring they meet Olympus’ quality and performance specifications Person Specification: Education A degree or higher qualification in Computer Science, Digital Systems Engineering, Software Engineering from a recognized institute. A master’s in digital systems or software engineering will be an added advantage. Experience Proven track record in creating and establishing software R&D teams in a global set up with the ability to create structures and framework for global development and partnership in organizations with varying maturity levels 14+ years of overall experience in digital engineering, cloud systems, AI/ML development, or related fields with 10+ years in medical devices domain 5+ years of experience with a medical devices or technology company in a leadership role 9+ years of experience in software development, data engineering, cloud computing, and AI/ML Strong understanding of medical device regulations (ISO 13485, FDA 21 CFR Part 820, etc.) Proven track record of leading teams in the design and development of digital systems and software solutions Skills Strong technical background in digital engineering, cloud architecture, software integration, and AI/ML with experience in Medical Device development and/or sustaining digital engineering efforts Expertise in managing R&D engineering projects, including performance tracking, SLA/KPI definition, contract negotiation, and demand planning Proven ability to work through digital system lifecycle management, including FDA Design Controls and international standards (e.g., ISO14971, IEC60601), ensuring alignment with strategic roadmaps Familiarity with AI/ML technologies and their application in medical devices for diagnostics, data analysis, or predictive modeling Experience with digital platforms for remote patient monitoring, telemedicine, or mobile health (mHealth) Proficiency in using modern software development tools and methodologies, such as Agile, DevOps, and CI/CD pipelines Knowledge of user-centered design and the development of intuitive user interfaces (UI) for medical devices Experience with cybersecurity risk management for connected and networked medical devices Experience in Project and Program Management, with a focus on vendor partner management, continuous improvement, and talent growth Familiarity with cloud platforms (AWS, Azure, Google Cloud) and AI/ML development tools (TensorFlow, PyTorch) ensuring cross-functional collaboration to achieve business objectives Capable of developing deliverables to document digital system designs for scalability, security, and compliance Experience planning and mitigating cybersecurity risks using tools like threat modeling and penetration testing Strong knowledge of data engineering, data processing pipelines, and cloud-based data storage for medical device software Proficiency in working with agile development processes, conducting risk analyses, and software FMEAs Effective communication skills, both verbal and written, with the ability to present information clearly to cross-functional teams, vendor partners, and leadership and stakeholder management Strong project management skills, with the ability to manage multiple projects simultaneously Excellent communication, leadership, and problem-solving skills Show more Show less
Hyderabad, Telangana, India
Not disclosed
On-site
Full Time
About the Company: Olympus Corporation is a globally renowned leader in endoscopy enabled healthcare, pioneering innovative solutions that enhance people's lives every day. With a rich history spanning nearly a century, Olympus has continuously pushed the boundaries of what's possible in the realms of medical, scientific, and imaging technology. Since its inception, Olympus has remained committed to its founding principles of integrity, innovation, and quality. Over the years, the company has diversified its portfolio, excelling in various fields including endoscopy, microscopy, life sciences, and digital imaging. Purpose of the Role: The Staff Embedded Software Engineer will focus on the technical execution of embedded software development projects within Olympus. Reporting to the Associate Director, this role emphasizes technical leadership while maintaining some project management responsibilities. The individual will collaborate closely with PMO to drive the design, development, and troubleshooting of embedded software systems for medical devices. This position will take charge of strategic technical oversight, particularly in vendor partner management, ensuring high-quality engineering outcomes and adherence to regulatory standards such as FDA Design Controls. While contributing to project planning and delivery, the focus will be on leading technical initiatives, ensuring alignment with the broader R&D strategy and offshore operational goals. The role requires proactive liaison with internal teams and external partners to maintain seamless coordination and ensure the timely achievement of project milestones. Key Responsibilities: NPD and Stakeholder Management: Lead hands-on development and execution of embedded software, driving the implementation of complex systems from concept through to production, with a focus on achieving performance, reliability, and regulatory compliance in every phase Perform detailed design reviews with internal teams and vendor partners, offering technical expertise to refine embedded software architectures and ensuring they meet all Olympus R&D objectives Oversee the design, development, and deployment of embedded software and firmware for medical devices Ensure the integration of embedded systems with hardware components, sensors, user interfaces, and communication protocols Lead the development of real-time, safety-critical systems with a focus on reliability, efficiency, and performance Implement advanced embedded software engineering techniques and embedded systems validation. Collaborate with cross-functional teams (mechanical, hardware, and systems engineers) to ensure seamless integration of embedded software into overall product architecture and meet system-level requirements Provide technical mentorship to junior engineers and vendor partners, ensuring that best practices are followed and that technical decisions are aligned with Olympus’ long-term innovation strategies Ensure seamless communication of technical updates between stakeholders, including Olympus global teams, regulatory bodies, and vendor partners, focusing on detailed compliance and technical specifications Develop and validate test protocols for embedded software, ensuring designs are robust, reliable, and scalable while adhering to safety and regulatory standards Project Management: Lead technical tracking of project progress, developing detailed Gantt charts and project plans that map out technical milestones, dependencies, and resource needs for software R&D activities Coordinate with the PMO teams to ensure technical objectives are aligned with project timelines, adjusting designs and technical approaches to mitigate risks or delays Create and manage technical resource plans, ensuring that internal engineering teams and vendor partners have the tools, talent, and resources required to meet demanding project timelines Proactively troubleshoot and resolve technical challenges, leveraging advanced engineering methodologies like root cause analysis (RCA), failure mode effect analysis (FMEA), and reliability testing to resolve bottlenecks Support RAID management by identifying and documenting key technical risks, ensuring that each risk has an associated mitigation plan grounded in strong engineering fundamentals Provide in-depth technical reports to the PMO on project progress, focusing on design validation, testing outcomes, technical issues encountered, and proposed engineering solutions Oversee technical escalations, ensuring that all technical roadblocks are swiftly identified and addressed, with proposed solutions backed by solid technical rationale Practice Development: Lead technical setup of development tools and workflows, including implementing software for embedded systems, debugging tools, and testing protocols for streamlined development within the function Develop and oversee technical processes, including change control, design reviews, and prototype testing, ensuring the function operates with cutting-edge engineering efficiency Establish advanced testing and validation protocols, ensuring that all embedded software developed in the function meets high standards for performance, durability, and compliance Direct hands-on debugging and software validation, focusing on early-stage system validation, software integration, and design tuning to meet evolving project needs Drive continuous improvement initiatives to optimize technical workflows, reduce development cycles, and improve overall engineering output quality by integrating feedback from testing and real-world results Ensure all software designs meet global regulatory and safety standards, working closely with regulatory bodies and certification teams to ensure the function’s output aligns with industry regulations Manage technical knowledge-sharing sessions within the function, facilitating the exchange of embedded software know-how between internal teams and external vendor partners to elevate the overall technical skill set Regulatory & Compliance: Support the Associate Director in ensuring product development aligns with regulatory and industry standards, including FDA, CE, ISO, and other relevant certifications Assist in engaging with external teams and certification bodies to ensure compliance with applicable safety standards Help maintain documentation in accordance with Good Manufacturing Practices (GMP) and quality system regulations Risk Management & Problem-Solving: Work with the team to identify technical risks and support the development of mitigation strategies Provide input and technical support to address engineering challenges throughout the product development process Person Specification: Education A degree or higher qualification in Computer Science Engineering from a recognized university. Master's in computer Science Engineering will be an added advantage. Experience 10+ years of experience in embedded software development, with a mix of technical and managerial responsibilities Proven experience in collaborating with PMOs and global teams on embedded software engineering projects Strong technical background in embedded software and firmware development Experience in medical device development is preferred Skills Strong technical expertise in embedded systems engineering, including hands-on experience in R&D and/or sustaining engineering, especially in product development environments Experience working with vendor partners on R&D projects, assisting in performance tracking, SLA monitoring, and supporting demand planning to ensure alignment with project requirements Strong experience in developing embedded software and firmware for medical devices, including real-time operating systems (RTOS) and safety-critical systems Proficient in programming languages such as C, C++, and assembly, with expertise in low-level hardware interaction and device drivers Strong understanding of microcontroller, microprocessor, and digital signal processing (DSP) architectures Experience with wireless communication protocols (e.g., Bluetooth, Wi-Fi) and cybersecurity in medical devices Familiarity with medical device product lifecycle management, with experience in applying FDA Design Controls and international standards (e.g., 820-CFR, ISO14971, IEC62304), ensuring compliance with project-specific regulations Experience in supporting project and program management efforts, with a focus on managing day-to-day vendor partner interactions, driving continuous improvement in engineering processes, and contributing to team growth Comfortable working in Agile SCRUM and stage-gate environments, ensuring collaboration with cross-functional teams to meet project objectives Ability to develop and contribute to design documentation, including source code documentation, technical specifications, and compliance records for manufacturability and quality assurance Knowledge of real-time systems, software development and device drivers, contributing to design solutions to mitigate risks Understanding of software lifecycle management, software verification, and validation for embedded systems, including experience with managing design for reliability and scalability Experience with requirements management systems contributing to risk analysis and DFMEA processes in embedded software R&D projects Effective stakeholder management skills, collaborating with PMO teams to ensure technical alignment and timely project delivery Experience working with project data, contributing to technical assessments and identifying opportunities for process improvements and operational efficiency Strong communication skills, with the ability to present technical updates and information clearly to cross-functional teams and stakeholders Show more Show less
India
Not disclosed
On-site
Full Time
Purpose of the Role - The Senior Enterprise Architect for ERP is responsible for developing a forward-looking technology strategy and roadmap for ERP, which translates business vision and objectives into ERP-related technology initiatives and investments and influences senior business and IT stakeholders to adopt their vision. The Senior Enterprise Architect for ERP manages architecture resource to design and evolve the strategy and roadmap within their domain and deliver the architecture principles to support design and implementation. Primary Duties and Responsibilities - ERP System Design and Architecture • Lead the design and development of ERP system architecture that supports the organization's business requirements and future goals. • Define the integration architecture for ERP modules, ensuring seamless communication and data flow across different functional areas. • Evaluate and select ERP software solutions based on technical requirements, scalability, and alignment with business needs. • Develop architectural blueprints and technical documentation outlining system configurations, modules, interfaces, and data structures. ERP Technology Roadmap and Strategy • Collaborate with senior management and stakeholders to define the ERP technology roadmap aligned with business objectives. • Identify opportunities to enhance existing ERP capabilities and propose innovative solutions to address business challenges. • Conduct feasibility studies and impact assessments for proposed technology investments and upgrades. • Provide technical leadership and guidance on ERP system implementations, ensuring adherence to best practices and standards. ERP Integration and Interoperability • Design and oversee the integration of ERP systems with other enterprise applications. • Establish standards and protocols for data exchange and interoperability between ERP modules and external systems. • Work closely with development teams to implement integration solutions and resolve technical issues during integration phases. • Monitor and optimize system performance to ensure efficient data transfer and processing across integrated platforms. ERP Performance Optimization and Scalability • Define performance metrics and benchmarks for ERP systems to monitor and optimize system performance. • Conduct capacity planning and scalability assessments to accommodate business growth and increased user demand. • Implement performance tuning strategies and recommend infrastructure enhancements to improve system responsiveness and reliability. • Collaborate with infrastructure teams to ensure hardware and network resources meet ERP system requirements and performance expectations. Manufacturing and Supply Chain Management (SCM) • Conduct assessments of current Manufacturing and SCM processes, systems, and technologies to identify areas for ERP-related improvement and innovation. • Evaluate and select Manufacturing and SCM technologies, platforms, and solutions, related to ERP, that align with organizational needs, scalability requirements, and budget constraints. • Align Manufacturing and SCM ERP strategies with Enterprise Architecture principles, ensuring scalability, integration, and alignment with business continuity plans. • Lead the design and development of Manufacturing and SCM ERP system architecture, including integration with ERP systems. • Provide recommendations on technology adoption, integration strategies, and phased deployment approaches based on risk assessment and business impact analysis. Minimum Qualifications - Education • Bachelor’s degree or higher in Computer Science, Engineering (or equivalent and related experience preferred). Experience • Minimum 10 years' experience as an Enterprise Architect focused with touchpoints in Manufacturing and Supply Chain Management and ERP systems. • Multi-year operational experience in S/4 Hana Architecture with active involvement in architectural work in S/4 Hana implementations. • Active membership in SAP EA Forum(s) preferred. • Experience in the Medical Technology industry, either in a MedTech company or in a Life Science Consulting company preferred. • Extensive experience with architectural frameworks such as TOGAF (The Open Group Architecture Framework), Zachman, etc. • Extensive experience in software engineering and design architecture. • Significant experience in defining architecture policies and frameworks. • Advanced understanding of business analysis techniques and processes. • Knowledge and experience in project management, process modelling, data modelling and systems analysis. • Demonstrable knowledge of contributing to business aligned Technology strategies. • Expert knowledge of technology integrations. • Understanding of technology security and regulatory requirements. • Understanding of technology trends. • In-depth knowledge of working with business processes in the assigned domain, preferably in medical related fields. Technical Competencies • Strong understanding in Manufacturing and SCM processes, technologies (e.g., MES, WMS, TMS, SCM analytics), and industry trends. • Strong understanding of Manufacturing and Supply Chain Management ERP system architectures, integration techniques, and enterprise application principles. Show more Show less
Hyderabad, Telangana, India
Not disclosed
On-site
Full Time
About the Company: Olympus Corporation is a globally renowned leader in endoscopy enabled healthcare, pioneering innovative solutions that enhance people's lives every day. With a rich history spanning nearly a century, Olympus has continuously pushed the boundaries of what's possible in the realms of medical, scientific, and imaging technology. Since its inception, Olympus has remained committed to its founding principles of integrity, innovation, and quality. Over the years, the company has diversified its portfolio, excelling in various fields including endoscopy, microscopy, life sciences, and digital imaging. Purpose of the Role: The Senior Manager will act as the head of system engineering R&D and the business process owner for Olympus’s Standard Operating Procedures related to product development (e.g., Systems Design, Systems Integration, Verification, Validation, Design & Development Planning, Requirements Engineering, etc.). The individual will function as a steward of our product development processes, ensuring alignment with Olympus' global system engineering strategy. The ideal candidate shall be a hands-on technical leader with extensive experience in developing medical systems. This role will involve setting up the system engineering R&D function for India scope and managing system engineering projects, ensuring seamless collaboration with Olympus’ global R&D and India leaders. The incumbent will be responsible for technical oversight, driving project delivery, and ensuring that projects meet the company’s product development standards with minimal operational input from Olympus HQ. This role will also ensure high-quality engineering outcomes in the development of medical systems by leading the systems engineering team through the design, verification, and validation processes. By overseeing the systems engineering function, this individual will ensure compliance with regulatory standards such as FDA Design Controls and ISO requirements. The position requires strong leadership, technical proficiency, and the ability to align system R&D activities with Olympus’ offshore vision. Key Responsibilities: Functional Setup: Lead the functional setup and management of the system engineering function, optimizing workflows, task assignment, hiring/team set-up, and resource management Seek to ideate enhancements to systems engineering processes and tools with the goal of increasing product development efficiency, communication, and/or quality Collaborate with global PMO teams to ensure the engineering R&D function growth roadmap is aligned with Olympus’ long-term R&D strategy and technical priorities Develop and oversee technical training and knowledge-sharing programs for internal teams, fostering continuous skill development and alignment with Olympus’ technical standards Work closely with the PMO to manage demand planning and resource forecasting for the function, ensuring sufficient talent and infrastructure for current and future systems engineering projects Implement continuous improvement initiatives within the system engineering function, driving technical process enhancements and increasing the efficiency and quality of product development across teams Identify and implement cutting-edge technologies and systems engineering practices to improve product performance and drive innovation Recruit staff, develop them through assignments, guidance, and mentorship, and manage their performance Create systems to ensure all updates/changes are communicated across sites/employees NPD and Stakeholder Management: Head the system engineering function to own and account for the delivery, execution, and management of all NPD activities within the India scope of system engineering Provide strategic oversight and guidance for system R&D projects, ensuring external and internal teams align with performance specifications, regulatory standards, and Olympus’ overall R&D objectives Drive the development and maintenance of system architecture, including hardware, software, and firmware integration Collaborate with Olympus PMO teams to develop and monitor technical roadmaps, ensuring smooth execution of project goals and resource allocations Act as the subject matter expert on system design control, providing guidance to product development teams (both internal and external) Ensure system designs are optimized for performance, manufacturability, safety, and reliability Stay current with emerging technologies and advancements relevant to medical device systems engineering Ensure that system design solutions meet performance, cost, manufacturability, and safety requirements through effective review and communication with global stakeholders Drive the development of IP strategies by working with PMO and legal teams, ensuring vendor partners adhere to Olympus’ requirements for protecting intellectual property in system designs Facilitate technical problem-solving by coordinating with global leads, ensuring swift resolution of challenges and minimizing project delays Champion continuous improvement initiatives for systems engineering processes, tools, and methodologies Drive innovation in medical device design and engineering practices to enhance product quality and reduce time to market Project Management: Head the Systems Engineering R&D function to serve as the strategic interface between global PMO and vendor partners, providing updates on technical progress, risks, and issues while ensuring alignment with the overall R&D strategy Develop and manage technical roadmaps with input from vendor partners, ensuring timelines, milestones, and resource planning are optimized for the systems engineering function Regularly report project status to PMO leads and Olympus global teams, ensuring visibility of key technical achievements and roadblocks, and adjusting strategies as needed Manage and oversee the maintenance of technical RAID logs, working with vendor partners to ensure risks are identified, escalated, and addressed promptly Oversee coordination between vendor partners and software development teams to ensure seamless integration of system designs into broader product architectures Ensure adherence to Olympus’ design control procedures and drive continuous improvements in these processes to enhance clarity, compliance, and usability Lead design reviews, technical assessments, and decision-making processes to ensure project milestones are met Provide high-level guidance on the verification and validation testing strategies proposed, ensuring they meet Olympus’ quality and performance specifications Regulatory & Compliance: Ensure that all product development activities meet regulatory and industry standards, including FDA, CE, ISO, and other relevant certifications Act as the point of escalation for technical and regulatory compliance matters, ensuring external and internal teams engage with safety certification bodies and comply with applicable standards Manage systems requirements, traceability, and change management to ensure clear documentation and compliance with design controls Risk Management & Problem-Solving: Identify potential technical risks and implement mitigation strategies Provide technical guidance in solving engineering challenges during the product development lifecycle Person Specification: Education A degree or higher qualification in Systems Engineering, Biomedical Engineering, or related fields from a recognized university. Master's in systems engineering will be an added advantage. Experience 14+ years of overall experience in systems engineering or medical device development with 10+ years in medical devices domain 5+ years of experience with a medical devices company in a leadership role 9+ years of experience in system development, system integration, and product design Strong understanding of medical device regulations (ISO 13485, FDA 21 CFR Part 820, etc.) Proven track record of leading teams in the design and development of Class II/III medical systems Skills Strong technical background in systems engineering, system integration, and model-based engineering, with experience in Medical Device development and/or sustaining engineering efforts Expertise in managing R&D engineering projects, including performance tracking, SLA/KPI definition, contract negotiation, and demand planning Proven ability to work through medical device product lifecycle management, including FDA Design Controls and international standards (e.g., 820-CFR, ISO14971, IEC60601), ensuring alignment with strategic roadmaps Experience in Project and Program Management, with a focus on vendor partner management, continuous improvement, and talent growth Familiarity with Model-Based Systems Engineering (MBSE) and requirements management tools, ensuring cross-functional collaboration to achieve business objectives Capable of developing deliverables to document system designs for high-volume manufacturing and quality compliance Experience planning and mitigating system-level risks using tools like FMEA and fault tree analysis Strong knowledge of system integration methodologies for medical devices and the ability to solve complex technical problems with sound judgment Proficiency in working with requirements management systems, conducting risk analyses and DFMEAs Excellent stakeholder management skills across PMO leads and vendor partners, ensuring timely project delivery and alignment with strategic goals Effective communication skills, both verbal and written, with the ability to present information clearly to cross-functional teams, vendor partners, and leadership Strong project management skills, with the ability to manage multiple projects simultaneously Excellent communication, leadership, and problem-solving skills Show more Show less
Hyderabad, Telangana, India
Not disclosed
On-site
Full Time
About the Company: Olympus Corporation is a globally renowned leader in endoscopy enabled healthcare, pioneering innovative solutions that enhance people's lives every day. With a rich history spanning nearly a century, Olympus has continuously pushed the boundaries of what's possible in the realms of medical, scientific, and imaging technology. Since its inception, Olympus has remained committed to its founding principles of integrity, innovation, and quality. Over the years, the company has diversified its portfolio, excelling in various fields including endoscopy, microscopy, life sciences, and digital imaging. Purpose of the Role: The Staff Electrical Engineer will focus on the technical execution of electrical engineering projects within Olympus. Reporting to the Associate Director, this role emphasizes technical leadership while maintaining some project management responsibilities. The individual will collaborate closely with Global R&D and India leads to drive the design, development, and troubleshooting of electrical systems for medical devices. This position will take charge of strategic technical oversight, particularly in vendor partner management, ensuring high-quality engineering outcomes and adherence to regulatory standards such as FDA Design Controls. While contributing to project planning and delivery, the focus will be on leading technical initiatives, ensuring alignment with the broader R&D strategy and offshore operational goals. The role requires proactive liaison with internal teams and external teams to maintain seamless coordination and ensure the timely achievement of project milestones. Key Responsibilities: NPD and Stakeholder Management: Lead hands-on development and execution of electrical designs, driving the implementation of complex electrical systems from concept through to production. Focus on achieving performance, reliability, and regulatory compliance in every phase Oversee the design and development of electrical systems, including circuit design, PCB layout, power management, and signal processing for medical devices Ensure designs are optimized for safety, reliability, manufacturability, and compliance with medical device standards Manage the selection and integration of components, sensors, and electronic systems that meet design requirements and regulatory standards Perform detailed design reviews with internal teams and vendor partner, offering technical expertise to refine electrical architectures and ensuring they meet all Olympus R&D objectives Implement advanced electrical engineering techniques, such as circuit simulation, power analysis, thermal modeling, and PCB design optimization, to drive high performance and reliability Collaborate with cross-functional teams (mechanical, software, systems engineers) to ensure seamless integration of electrical designs into overall product architecture and meet system-level requirements Provide technical mentorship to junior engineers and vendor partner, ensuring that best practices are followed and that technical decisions are aligned with Olympus’ long-term innovation strategies Ensure seamless communication of technical updates between stakeholders, including Olympus global teams, regulatory bodies, and vendor partner, focusing on detailed design compliance and technical specifications Develop and validate test protocols for electrical systems, ensuring designs are robust, reliable, and scalable while adhering to safety and regulatory standards Drive innovation in electrical design, implementing new technologies to improve the functionality, performance, and reliability of medical devices Identify and implement process improvements for electrical engineering design, testing, and validation to optimize product development Project Management: Lead technical tracking of project progress, developing detailed Gantt charts and project plans that map out technical milestones, dependencies, and resource needs for electrical R&D activities Coordinate with the PMO teams to ensure technical objectives are aligned with project timelines, adjusting designs and technical approaches to mitigate risks or delays Create and manage technical resource plans, ensuring that internal engineering teams and vendor partner have the tools, talent, and resources required to meet demanding project timelines Proactively troubleshoot and resolve technical challenges, leveraging advanced engineering methodologies like root cause analysis (RCA), failure mode effect analysis (FMEA), and reliability testing to resolve bottlenecks Support RAID management by identifying and documenting key technical risks, ensuring that each risk has an associated mitigation plan grounded in strong engineering fundamentals Provide in-depth technical reports to the PMO on project progress, focusing on design validation, testing outcomes, technical issues encountered, and proposed engineering solutions Oversee technical escalations, ensuring that all technical roadblocks are swiftly identified and addressed, with proposed solutions backed by solid technical rationale Practice Development: Lead technical setup of engineering tools and workflows, including implementing software for electrical design (e.g., Altium, MATLAB, SPICE), lab setups, and testing protocols for streamlined development within the function Develop and oversee technical processes, including change control, design reviews, and prototype testing, ensuring the function operates with cutting-edge engineering efficiency Establish advanced testing and validation protocols, ensuring that all electrical systems developed in the function meet high standards for performance, durability, and compliance Direct hands-on prototyping and debugging, focusing on early-stage system validation, component selection, and electrical design tuning to meet evolving project needs Drive continuous improvement initiatives to optimize technical workflows, reduce design cycles, and improve overall engineering output quality by integrating feedback from testing and real-world results Ensure all electrical designs meet global regulatory and safety standards, working closely with regulatory bodies and certification teams to ensure the function’s output aligns with industry regulations Manage technical knowledge-sharing sessions within the function, facilitating the exchange of engineering know-how between internal teams and external vendor partner to elevate the overall technical skill set Regulatory & Compliance: Support the Associate Director in ensuring product development aligns with regulatory and industry standards, including FDA, CE, ISO, and other relevant certifications Assist in engaging with external teams and certification bodies to ensure compliance with applicable safety standards Help maintain documentation in accordance with Good Manufacturing Practices (GMP) and quality system regulations Risk Management & Problem-Solving: Work with the team to identify technical risks and support the development of mitigation strategies Provide input and technical support to address engineering challenges throughout the product development process Person Specification: Education A degree or higher qualification in Biomedical / Electrical Engineering from a recognized university. Master’s in biomedical /electrical engineering will be an added advantage. Experience 10+ years of experience in electrical engineering R&D in the medical devices domain, with a mix of technical and managerial responsibilities Proven experience in collaborating with PMOs and global teams on electrical projects Strong technical background in electrical design, circuit board development, and compliance with regulatory standards Experience in medical device development is preferred Skills Strong technical expertise in electrical engineering, electronics, and mechatronics, with hands-on experience in R&D and/or sustaining engineering, especially in product development environments Proficient in circuit design, PCB layout, power management, analog and digital signal processing, and microcontroller-based systems Experience with electromagnetic compatibility (EMC) testing, electrical safety, and risk management practices Experience working with vendor partner on R&D projects, assisting in performance tracking, SLA monitoring, and supporting demand planning to ensure alignment with project requirements Familiarity with medical device product lifecycle management, with experience in applying FDA Design Controls and international standards (e.g., 820-CFR, ISO14971, IEC60601), ensuring compliance with project-specific regulations Comfortable working in Agile SCRUM and stage-gate environments, ensuring collaboration with cross-functional teams to meet project objectives Ability to develop and contribute to design documentation, including schematics, specifications, and compliance records for manufacturability and quality assurance Technical proficiency in PCB design tools (Altium/OrCAD), with the ability to review and provide feedback on schematics, component selection, and PCB manufacturing outputs Understanding of electromagnetic compatibility (EMC) challenges in electrical designs, contributing to design solutions to mitigate risks Knowledge of manufacturing processes for electrical components and an ability to assist in resolving complex technical issues with a practical approach Experience with requirements management systems (e.g., DOORS, JAMA), contributing to risk analysis and DFMEA processes in electrical R&D projects Effective stakeholder management skills, collaborating with PMO teams to ensure technical alignment and timely project delivery Strong communication skills, with the ability to present technical updates and information clearly to cross-functional teams and stakeholders Show more Show less
Gurugram, Haryana, India
Not disclosed
On-site
Full Time
About Olympus : Olympus Medical Systems India is a wholly owned subsidiary of Olympus Corporation, Japan. Taking a plunge into the Indian market, team at Olympus wants to be the most respected reliable and chosen brand in health care domain. Olympus established its direct presence to build a very strong marketing and service facilities. With better and innovative technology, Olympus looks forward to grow its foothold into the market with the growth in Indian Economy. Role Overview: Hiring for an Engineer - Technical Service (Inhouse Endoscopy Repair) at our Gurgaon office (HQ). If you are passionate about medical technology and have experience in repairing Medical/Electronic equipment's, we would love to hear from you! Responsibilities: • In House Repair of Medical Devices: Disassembly & assembly of flexible Endoscope. • Should be able to perform Cable stripping, Wire soldering, Precise work under Microscope. • To take corrective actions & preventive actions against failure of KPI’s . • To achieve Repair lead time. • To maintain high level of repair quality. • To increase repair productivity with time. • Responsible to maintain 5S condition of Repair Centre / responsible area. • Should have adequate communication skills (written and verbal). Education Qualification: B. Tech/Diploma in Electrical / Electronics/ Bio Medical Engineering. Experience Required : 1-5 years of experience in repair of Medical/Electronical devices. Show more Show less
Mumbai, Maharashtra, India
None Not disclosed
On-site
Full Time
Below are the Roles & Responsibilities: Location- West Mumbai To cater Field services to SP customers Should be able to handle given territory individually with following assignments Carry out the Preventive Maintenance on time of all SP Products Attend breakdown call within time limits and provide onsite solution if possible. Installation of equipment's within time limits. Conduct training session on request or at pre decided site (care at sight). Follow up of pending payment by sending letters/mails/personal visits against service(repair and contract and Accessories). Support in conference and workshop arranged by marketing team. Negotiate on commercial aspect with customer and technical explanation of repair quotation. Increase in AMC penetration based on Installation base/ penetration ratio data. Support and participate in full day training sessions (SP course) Sales of accessory (which are directly sold through OMSI) Preferred candidate profile Education: Technical (Diploma or BE/B Tech) must have basic knowledge in excel, word, power point. Should be open to travel extensively. Should be minimum graduate in science stream. Should have minimum of 2yrs and above work experience in medical equipment/service industry. Interested candidates, please mail your resume to taru.arora@olympus.com Regards HR Team
Lucknow, Uttar Pradesh, India
None Not disclosed
On-site
Full Time
Below are the roles & responsibilities: The Sr. Executive – Sales (GIR) will be responsible for carrying out sales function & activities in the assigned territory. Based in the designated location for GI & Respiratory products and will be responsible of the complete designated territory. • Ensure Customer call & coverage across the territory individually and along with his direct team members. • Handling Distributor’s sale & marketing activity. • Regularly Conducting live GI&R products demo. • Ensure implementation of marketing plan in territory and conducting market development activities. • Gathering market, competition, key customer data through his team members • Weekly Reporting of all the sales activities on SFDC. • Regular discussion and engagement of customers for increase of installation base with the help of using right tools. • Maintain PCL accuracy and strong pipeline of leads. • Develop and Manage KOL’s. • Negotiating contracts • Meeting both the business and scientific needs of healthcare professionals • Attending and organizing trade exhibitions, conferences and meetings • Managing budgets Educational Qualification & Experience • Should be minimum graduate or above in science stream • Should have minimum working experience of 5-7 years in medical equipment/capital equipment/surgical industry. Others • Should have basic knowledge in Excel, Word, Powerpoint. • Should be open to travel extensively Interested candidates, please share your resume to taru.arora@olympus.com. Regards HR Team
Ahmedabad, Gujarat, India
None Not disclosed
On-site
Full Time
Below are the roles & responsibilities: Executive/Senior -Sales (GS+URO+GYN) will be responsible for carrying out sales function & activity functions in the designated territory. He will be primarily responsible for generating leads and achieving sales targets for the Surgical products in his/her region. Generate enquiries/Leads for Company’s product line. Ensure Customer call & coverage across the designated territory for self as per organization policy. Organizing appointments and meetings with community- and hospital-based healthcare staff identifying and establishing new business. Demonstrating or presenting products to healthcare staff including doctors, nurses and pharmacists undertaking relevant research. Conduct in-depth presentations and product demonstrations to healthcare professionals, highlighting the clinical benefits and value proposition of our offerings. Handling Distributor’s effectively for sale & coverage. Manage and nurture a pipeline of opportunities, effectively moving them through the sales process. Develop and Manage HCP’s. Collaborate effectively with internal teams, including marketing, FSE, regulatory, and customer support, to ensure seamless customer experience. Keep close track of competitor activity and inform the management on a timely basis. Networking at the right levels to keep track of development / growth / new projects coming up in the region. Identify opportunities in Govt Tenders and work towards participating in the same to get business for the company. Sales forecasts on a monthly, quarterly and Annual basis so as to achieve budgets. Maintaining accurate records of customer interactions and sales activities; generate timely reports for management review. Representing the company at medical conferences, trade shows, and workshops to showcase products. Negotiating and closing the deal with customers. Meeting both the business and scientific needs of healthcare professionals Managing budgets Qualification & Experience Should be minimum graduate or above in science stream Should be well versed with MS-Word, Excel, PowerPoint. Should have minimum working experience of 5-7 years in the medical equipment/surgical industry. Others Negotiation skills Should be open to travel extensively Maintains professional image that reflects positively on the Company Excellent communication, negotiation, and relationship-building skills. Interested candidates, please mail your resume to taru.arora@olympus.com. Regards HR Team
Hyderabad, Telangana, India
None Not disclosed
On-site
Full Time
Purpose of the Role: The Head of Electrical Engineering will act as the head of electrical R&D and the business process owner for Olympus’s Standard Operating Procedures related to product development (e.g,. Design Controls, Verification, Validation, Design & Development Planning, User & Product Requirements, Administer and obtain Requirements tools, Etc.), and function as a steward of our product development processes. The ideal candidate shall be a hands-on technical leader with extensive experience in developing medical devices and systems. The individual will be responsible for setting up the engineering R&D function for global scope of work and own the execution of engineering projects, ensuring alignment with Olympus’ global R&D strategy. This role is responsible for driving the engineering R&D scope of work, focusing on leading engineering teams and project delivery in collaboration with the Olympus’ global R&D and India leaders. The incumbent will spearhead project planning, budget management, and technical oversight, ensuring seamless coordination across teams to meet project timelines and deliverables with minimal operational input from Olympus HQ. On the technical front, this role will provide strategic oversight to the center while ensuring high-quality engineering outcomes in the development of medical devices. By leading electrical engineering initiatives, this individual will guide the design, verification, and validation processes, ensuring compliance with regulatory standards such as FDA Design Controls. The position demands a strong mix of technical proficiency and proactive project leadership, fostering a collaborative environment that aligns the electrical R&D performance with Olympus’ offshore vision. Key Responsibilities: Functional Setup: Lead the functional setup and management of the electrical function, optimizing workflows, task assignment, hiring/team set-up and resource management Seek to ideate enhancements to systems and processes with the goal of increasing product development efficiency, communication, and/or quality Collaborate with global PMO teams to ensure the engineering R&D function growth roadmap is aligned with Olympus’ long-term R&D strategy and technical priorities Develop and oversee technical training and knowledge-sharing programs for internal teams, fostering continuous skill development and alignment with Olympus’ technical standards Work closely with the PMO to manage demand planning and resource forecasting for the function, ensuring sufficient talent and infrastructure for current and future electrical projects Implement continuous improvement initiatives within the electrical engineering function, driving technical process enhancements and increasing the efficiency and quality of product development across teams Identify and implement cutting-edge technologies and engineering practices to improve product performance and drive innovation Participate in strategic planning and provide technical insights to support long-term growth and competitiveness Recruit staff, develop them through assignments, guidance, and mentorship, and manage their performance Create systems to ensure all updates/changes are communicated across sites/employees NPD and Stakeholder Management: Head the electrical engineering function to own and account for the delivery, execution and management of all NPD activities within the India scope of electrical engineering Provide strategic oversight and guidance for electrical R&D projects, ensuring external and internal teams align with performance specifications, regulatory standards, and Olympus’ overall R&D objectives Oversee the design and development of electrical systems, including circuit design, PCB layout, power management, and signal processing for medical devices Ensure designs are optimized for safety, reliability, manufacturability, and compliance with medical device standards Manage the selection and integration of components, sensors, and electronic systems that meet design requirements and regulatory standards Collaborate with Olympus PMO teams to develop and monitor technical roadmaps, ensuring smooth execution of project goals and resource allocations Act as the subject matter expert on design control for electrical R&D, provide guidance to product development teams (both internal and external) Ensure that design solutions meet performance, cost, manufacturability, and safety requirements through effective review and communication with global stakeholders Drive the development of IP strategies by working with PMO and legal teams, ensuring vendor partner adhere to Olympus’ requirements for protecting intellectual property in product designs Facilitate technical problem-solving by coordinating with global leads, ensuring swift resolution of challenges and minimizing project delays Project Management: Head the Engineering R&D function to serve as the strategic interface between global PMO and vendor partner, providing updates on technical progress, risks, and issues while ensuring alignment with the overall R&D strategy Develop and manage technical roadmaps with input from vendor partner, ensuring timelines, milestones, and resource planning are optimized for the electrical R&D function Regularly report project status to PMO leads and Olympus global teams, ensuring visibility of key technical achievements and roadblocks, and adjusting strategies as needed Manage and oversee the maintenance of technical RAID logs, working with vendor partner to ensure risks are identified, escalated, and addressed promptly Oversee coordination between vendor partner and software development teams to ensure seamless integration of electrical designs into broader product architectures Ensure adherence to Olympus’ design control procedures and drive continuous improvements in these processes to enhance clarity, compliance, and usability Provide high-level guidance on the verification and validation testing strategies proposed, ensuring they meet Olympus’ quality and performance specifications Regulatory & Compliance: Ensure that electrical designs meet relevant regulatory standards (IEC 60601, ISO 13485, FDA 21 CFR Part 820) and safety standards (UL, CE) Lead risk management activities, including electrical safety analysis, electromagnetic compatibility (EMC) testing, and failure modes and effects analysis (FMEA) Act as the point of escalation for technical and regulatory compliance matters, ensuring external and internal teams engage with safety certification bodies and comply with applicable standards Maintain documentation in compliance with Good Manufacturing Practices (GMP) and quality system regulations Risk Management & Problem-Solving: Identify potential technical risks and implement mitigation strategies Provide technical guidance in solving engineering challenges during the product development lifecycle Person Specification: Education A degree or higher qualification in Biomedical / Electrical Engineering from a recognized university. Masters in biomedical /electrical engineering will be an added advantage. Experience 14+ years of overall experience in medical or electrical engineering, maintenance, and management with 10+ years in medical devices domain 5+ years of experience with a medical devices company in a leadership role 9+ years of experience in medical device development, circuit boards, and product design Strong understanding of medical device regulations (ISO 13485, FDA 21 CFR Part 820, etc.) Proven track record of leading teams in the design and development of Class II/III medical devices Familiarity with product development lifecycle including concept, design, validation, and commercialization Skills Strong technical background in electrical engineering, electronics, and mechatronics, with experience in Medical Device development and/or sustaining engineering efforts Proficient in circuit design, PCB layout, power management, analog and digital signal processing, and microcontroller-based systems Expertise in managing R&D engineering projects, including performance tracking, SLA/KPI definition, contract negotiation, and demand planning Proven ability to work through medical device product lifecycle management, including FDA Design Controls and international standards (e.g., 820-CFR, ISO14971, IEC60601), ensuring alignment with strategic roadmaps Experience in Project and Program Management, with a focus on vendor partner management, continuous improvement, and talent growth Familiarity with Agile SCRUM environments and stage-gate processes, ensuring cross-functional collaboration to achieve business objectives Capable of developing deliverables to document product designs for high-volume manufacturing and quality compliance Technical expertise in printed circuit board design tools (Altium/OrCAD) and the ability to review schematics, component selection, and gerber data for PCB design and manufacturing Experience planning and mitigating electromagnetic compatibility challenges in electrical projects Strong knowledge of manufacturing methodologies for medical devices and the ability to solve complex technical problems with sound judgment Proficiency in working with requirements management systems like DOORS, JAMA, and conducting risk analyses and DFMEAs Excellent stakeholder management skills across PMO leads and vendor partner, ensuring timely project delivery and alignment with strategic goals Experience managing large data sets, financial analysis, and P&L ownership, utilizing these insights to drive process improvements and operational efficiencies Strong project management skills, with the ability to manage multiple projects simultaneously Excellent communication, leadership, and problem-solving skills
Hyderabad, Telangana, India
None Not disclosed
Remote
Full Time
About the Company: Olympus Corporation is a globally renowned leader in endoscopy enabled healthcare, pioneering innovative solutions that enhance people's lives every day. With a rich history spanning nearly a century, Olympus has continuously pushed the boundaries of what's possible in the realms of medical, scientific, and imaging technology. Since its inception, Olympus has remained committed to its founding principles of integrity, innovation, and quality. Over the years, the company has diversified its portfolio, excelling in various fields including endoscopy, microscopy, life sciences, and digital imaging Purpose of the Role: The Sr Manager, India will act as the head of digital engineering R&D and the business process owner for Olympus’s Standard Operating Procedures related to digital product development (e.g., Digital Systems Design, Cloud Architecture, Data Engineering, AI/ML Development, Software Integration, etc.), and function as a steward of our digital engineering processes. The ideal candidate will be a strategic thinker with a deep understanding of digital technologies and a proven track record of managing high-performing teams in a global environment. The ideal candidate will be a hands-on technical leader with extensive experience in digital systems development for medical devices or related industries. This individual will be responsible for setting up the Digital Unit engineering R&D function for the global scope of work and owning the execution of digital engineering projects, ensuring alignment with Olympus’ global R&D strategy. The role is responsible for driving the R&D Digital Unit engineering teams operations for India, focusing on leading digital engineering teams and project delivery in collaboration with the global leadership and India leadership teams. The incumbent will spearhead project planning, budget management, and technical oversight, ensuring seamless coordination across teams to meet project timelines and deliverables with minimal operational input from Olympus HQ. On the technical front, this role will provide strategic oversight while ensuring high-quality engineering outcomes in the development of digital systems and software. By leading digital engineering initiatives, this individual will guide the design, development, integration, and validation processes, ensuring compliance with regulatory standards such as FDA Design Controls, ISO, and IEC standards. The position demands a strong mix of technical proficiency and proactive project leadership, fostering a collaborative environment that aligns digital R&D performance with Olympus’ offshore vision. Key Responsibilities: The role is reporting to the Global Head of Digital Unit, the senior management representative and ambassador of the Digital Unit at the respective regional Hub lead The R&D India Head of Digital Unit will further develop the delivery scope and technology focus of the hub in alignment with global functions, with the aim of driving innovation, improving operational efficiency, building up capabilities, and enhancing both patient and customer experiences The role is intended to deliver a global “multiplier effect” by driving collaboration and coordination across the DU functions as well as in the region Functional Setup: Lead the functional setup and management of the digital engineering function, optimizing workflows, task assignments, hiring/team set-up, and resource management Ideate and implement enhancements to digital engineering processes and tools, aiming to increase product development efficiency, communication, and quality Collaborate with global DU R&D teams to ensure the digital engineering R&D function growth roadmap is aligned with Olympus’ long-term R&D strategy and technical priorities Develop and oversee technical training and knowledge-sharing programs for internal teams, fostering continuous skill development and alignment with Olympus’ digital standards Work closely with the global DU to manage demand planning and resource forecasting for the function, ensuring sufficient talent and infrastructure for current and future digital engineering projects Identify and implement cutting-edge technologies and digital engineering practices, such as cloud computing, data engineering, artificial intelligence (AI), and machine learning (ML) to improve product performance and drive innovation NPD and Stakeholder Management: Head the digital engineering function to own and account for the delivery, execution, and management of all NPD activities within the India scope of digital engineering Define and execute the digital strategy for medical devices in alignment with global Digital Strategy, focusing on software development, data analytics, cloud solutions, connectivity, and user experience Oversee the design and development of digital systems that enhance device functionality, data security, and remote monitoring capabilities Collaborate with Olympus DU R&D teams to develop and monitor technical roadmaps, ensuring smooth execution of project goals and resource allocations Ensure that digital engineering solutions meet performance, cost, scalability, and security requirements through effective review and communication with global stakeholders Solving by coordinating with global leads, ensuring swift resolution of challenges and minimizing project delays Drive innovation by identifying and implementing emerging technologies such as artificial intelligence (AI), machine learning (ML), and advanced data analytics into medical device systems Project Management: Head the India Digital Engineering R&D function to serve providing updates on technical progress, risks, and issues while ensuring alignment with the overall R&D strategy Develop and manage technical roadmaps with input from vendor partners, ensuring timelines, milestones, and resource planning are optimized for the digital engineering function Regularly report project status to Olympus global teams, ensuring visibility of key technical achievements and roadblocks, and adjusting strategies as needed Ensure adherence to Olympus’ digital system design control procedures and drive continuous improvements in these processes to enhance clarity, compliance, and usability Provide high-level guidance on digital system validation and testing strategies, ensuring they meet Olympus’ quality and performance specifications Person Specification: Education A degree or higher qualification in Computer Science, Digital Systems Engineering, Software Engineering from a recognized institute. A master’s in digital systems or software engineering will be an added advantage. Experience Proven track record in creating and establishing software R&D teams in a global set up with the ability to create structures and framework for global development and partnership in organizations with varying maturity levels 14+ years of overall experience in digital engineering, cloud systems, AI/ML development, or related fields with 10+ years in medical devices domain 5+ years of experience with a medical devices or technology company in a leadership role 9+ years of experience in software development, data engineering, cloud computing, and AI/ML Strong understanding of medical device regulations (ISO 13485, FDA 21 CFR Part 820, etc.) Proven track record of leading teams in the design and development of digital systems and software solutions Skills Strong technical background in digital engineering, cloud architecture, software integration, and AI/ML with experience in Medical Device development and/or sustaining digital engineering efforts Expertise in managing R&D engineering projects, including performance tracking, SLA/KPI definition, contract negotiation, and demand planning Proven ability to work through digital system lifecycle management, including FDA Design Controls and international standards (e.g., ISO14971, IEC60601), ensuring alignment with strategic roadmaps Familiarity with AI/ML technologies and their application in medical devices for diagnostics, data analysis, or predictive modeling Experience with digital platforms for remote patient monitoring, telemedicine, or mobile health (mHealth) Proficiency in using modern software development tools and methodologies, such as Agile, DevOps, and CI/CD pipelines Knowledge of user-centered design and the development of intuitive user interfaces (UI) for medical devices Experience with cybersecurity risk management for connected and networked medical devices Experience in Project and Program Management, with a focus on vendor partner management, continuous improvement, and talent growth Familiarity with cloud platforms (AWS, Azure, Google Cloud) and AI/ML development tools (TensorFlow, PyTorch) ensuring cross-functional collaboration to achieve business objectives Capable of developing deliverables to document digital system designs for scalability, security, and compliance Experience planning and mitigating cybersecurity risks using tools like threat modeling and penetration testing Strong knowledge of data engineering, data processing pipelines, and cloud-based data storage for medical device software Proficiency in working with agile development processes, conducting risk analyses, and software FMEAs Effective communication skills, both verbal and written, with the ability to present information clearly to cross-functional teams, vendor partners, and leadership and stakeholder management Strong project management skills, with the ability to manage multiple projects simultaneously Excellent communication, leadership, and problem-solving skills
India
None Not disclosed
Remote
Full Time
Purpose of the Role The Senior Salesforce Administrator is responsible for supporting the overall maintenance of the Salesforce platform. Acting as a central point of orchestration for developers, support teams, as well as end users, the administrator provides critical day to day support for deployment, user setup, data, monitoring, troubleshooting, enhancing, automating, reporting, upgrading and training of the platform. The Admin will also act as a first level SME for the Complaint Handling Process within the Trackwise system Primary Duties and Responsibilities Own the end to end administration of the Salesforce Platform including user management, workflows, and basic validations. Deployment of platform changes, by collaborating with the global platform, application development & support teams Provide expert support with setup and maintenance of reports and dashboards Plan and manage release & upgrade of environments covering Salesforce Seasonal Releases, Trackwise Releases & Regular Change Requests Perform data load activities on demand Support MDR & other Regulatory/Compliance related activities Collaborate with offshore support teams to manage incidents , change requests & integrations Supervision of incidents , change requests & integrations collaborating with the external vendor teams Competencies Development Support: Support new developer onboarding activities Release Execution: Responsible to execute releases from SF, Trackwise & Olympus changes. Issue Resolution: Troubleshoot and resolve complex technical issues in collaboration with development teams and vendor support. Support Key Users and manage their delegated administration Administration of DevOps Infrastructure, Sandbox Management (clone, refresh, etc) & related access Security Review: Support regular security review activities by extracting the relevant reports and working with the Application owner Minimum Qualification Education*: Bachelor’s Degree in IT or Engineering or Computer Applications Experience*: Certified in Salesforce Administration 3+ years in Salesforce Administration & DevOps activities 2+ years with Trackwise or a similar Quality Management System. Skills: Good knowledge of Salesforce architecture and related technologies Good knowledge on SF development best practices, objects Experience with Agile/Scrum Techniques and tools like JIRA. Strong communication (verbal/written/listening) skills. Good organizational skills with an eye for detail and able to work within a team setting. Experience working with and/or driving remote teams across continents and time zones is a huge benefit.
Gurugram, Haryana, India
None Not disclosed
On-site
Full Time
Below are the roles and responsibilities: Quality Management System: Ensure & Support that quality system requirements are effectively established and maintained in accordance with all applicable medical device regulations, preferably including ISO 13485, 21 CFR Part 820 (Current Good Manufacturing Practice (CGMP) regulations), and other standards. Proficient in understanding, review & align with relevant standard operating procedures as per the current technicalities with respect to QMS and other applicable regulatory requirements. Also ensure compliance of different functional QMS SOPs & Manuals. Proficient in Medical Device Labelling compliance (Including India Specific Requirements). Responsible for Execution of Actions for Nonconformance, CAPA, Change Management; Risk Evaluation and Impact assessment, Internal & External Audits / GAP Analysis (Surveys) – Existing SOP Surveys), Supplier Quality Management & Audits, Preparation and amendments of SOPs, Respective Training & Record Management, KPI Data Sourcing & details preparation for review meets. Understanding of Technical aspect and able to drive investigations in technical manner along with Technical department. Learn and Coordinate with Regional / Global Teams for relevant QMS procedures. Post Market Surveillance: Complaint Handling Process: Should be aware about the Indian guidelines for reporting AE/SAE complaints. Responsible for evaluation and assessment of any complaint/feedback from reporting point of view to authority. Responsible to support RA team to report the SAE/AE to CDSCO or its authorized centre. Recall and FCA Should be aware about the Indian and IMDRF countries guidelines about the Recall and FCA. Responsible for coordination with FSCA stakeholders, complaint assessment monitoring, and management of FSCA/Recall as per timeline and reporting of the same to CDSCO. Non-Conformity / CAPA Should be able to support activities towards reported non-conformities and prepare periodic reports, Hold NRBs and prepare NC details for meets, Learn and execute NC operations over Agile. CAPA management, learn Agile platform for CAPA operation. Hold CRB meets, monthly. Data Upkeepment / Training / Awareness Should be able to support QMS training & Awareness activities including data / record management. Should be able to timely prepare & upkeep key activities details for periodic reviews. Qualifications B. Tech / BME / – B. Pharma / M Pharma / M.Sc Biotechnology - Preferably with PG Diploma / QA and / or Preferred Certification (ISO13485 – Standard / Internal Auditor and/or LA and/or Risk Management (Medical Device) from reputed organization (such as TUV-SuD / BSI). Preferred Experience Minimum 4-7 years of working experience in a customer-oriented position in QA / QMS dept of an international organization, preferably the Medical Equipment / Device company. MS Office (focus Excel), Agile, Argus, etc. Fluent in oral/written communication (English). Preferable work experience on SFDC, EtQ, Track-Wise or Alike portal for execution of complaint initiation and handling. Interested candidates, please mail your resume to taru.arora@olympus.com. Regards HR Team
Lucknow, Uttar Pradesh, India
None Not disclosed
On-site
Contractual
Below are the roles and responsibilities: Note- Contract period of 1year To cater Field services to SP customers. Should be able to handle given territory individually with following assignments Carry out the Preventive Maintenance on time of all SP Products Attend breakdown call within time limits and provide onsite solution if possible. Installation of SP equipment’s within time limits. Conduct training session on request or at pre decided site (care at sight). Follow up of pending payment by sending letters/mails/personal visits against service(repair and contract and Accessories). Support in conference and workshop arranged by marketing team. Negotiate on commercial aspect with customer and technical explanation of repair quotation. Increase in AMC penetration based on Installation base/ penetration ratio data. Support and participate in full day training sessions (SP course) Sales of accessory (which are directly sold through OMSI) Qualification: Education: Technical (Diploma or BE/B Tech) must have basic knowledge in excel, word, power point. Should be open to travel extensively. Should be minimum graduate in science stream. Should have minimum of 2yrs and above work experience in medical equipment/service industry. Interested candidates, please mail your resumes to taru.arora@olympus.com Regards Team HR
Gurugram, Haryana, India
None Not disclosed
On-site
Full Time
About Olympus: Olympus Medical Systems India Private Limited commenced its business operation in Indian market on April 1, 2010. Olympus Medical Systems India is a wholly owned subsidiary of Olympus Corporation. Taking a plunge into the Indian market, team at Olympus wants to be the most respected reliable and chosen brand in health care domain. Olympus established its direct presence to build a very strong marketing and service facilities. With better and innovative technology, Olympus looks forward to growing its foothold into the market with the growth in Indian Economy. Business Overview: Olympus Medical Systems India has a wide portfolio of products that are equipped with the latest innovative and superiortechnology. Olympus deals primarily in three verticals i.e. Gastrointestinal, Respiration & Surgical divisions and contributeto the medical society with state of the art product categories that includes, Video Endoscopy, Endoscopic Ultrasound,Bronchoscopy, Endo therapy devices in Gastrointestinal & Respiratory range whereas Surgical division includes Highdefinition imaging system and Energy products to deal with Laparoscopy, General Surgery, Gynecology and Urology field. Olympus also has a wide range of Scientific Solutions Product into the non-medical segment. The Scientific Solutions Business provides microscopes, which Olympus has been manufacturing since its inception. These microscopes are used in various fields, whether for conducting such clinical examinations as blood tests or pathological examinations related to cancer diagnosis, assisting advanced research in the life science and medical fields, or performing quality control on manufacturing lines. Furthermore, the industrial video-scopes and ultrasonic flaw detectors offered in this business are used in inspections and examinations underpinning the safety of social infrastructure. The DM- Regulatory Affairs is responsible for Indian regulatory affairs activities related to the GI & Olympus products. DM- Regulatory Affairs is also responsible for advising and consulting with stakeholders about compliance with CDSCO Role Overview: BIS, WPC and other applicable regulatory bodies The DM- Regulatory Affairs will responsible for implement best practices, and contribute to both the strategic and operational functions of the regulatory affairs team. Illustrative Responsibilities Assesses: Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance .Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions.Identifies requirements and potential obstacles for market access distribution (federal/provincial/territorial state, reimbursement, purchasing groups, etc.) Assists in the development of regulatory strategy and updates strategy based upon regulatory changes. Evaluates proposed products for regulatory classification and jurisdiction Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities. Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization Compares regulatory outcomes with initial product concepts and recommends changes or refinements basedoninitial regulatory outcomes Negotiates with regulatory authorities throughout the product lifecycle Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation. Helps train stakeholders on current and new regulatory requirements to ensure organization wide compliance Assists other departments in the development of SOPs to ensure regulatory compliance Provides regulatory input and technical guidance on global regulatory requirements to product development teams. Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research processProvides regulatory information and guidance for proposed product claims/labelling .Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claimsPrepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.Monitors the progress of the regulatory authority review process through appropriate communications with the agency Communicates and interacts with regulatory authorities before and during the development and review of aregulatory submission through appropriate communication tools. Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees Minimum requirements: Qualification – M. Pharma/B Pharma along with PG Diploma in Drug Regulatory Affairs, Preferred Experience –•••Dedicated 12 to 15 years of working experience in a customer-oriented position in an international organization.MS Office (focus Excel)Fluent in oral/written communication (English) Competencies: Business Acumen:- Ability to tap into one's knowledge of the business environment to further the organization's agenda Customer focus (Internal and External):- Focusing effort towards achieving Customer Delight in line with Olympus' values Execution Excellence:- Ensuring seamless execution of organizational/ departmental strategy to achieve results as per Olympus’ quality standards Domain Expertise:- Applying one's knowledge and expertise for the benefit of the organization Communication:- Ability to effectively transmit one’s message across to the recipient Developing Organizational Talent:- Fostering a culture of development within the organization to fulfill individual as well as organizational aspirations Team Leadership:- Keeping a team motivated and engaged to work together towards organizational goals
haryana
INR Not disclosed
On-site
Full Time
As the DM- Regulatory Affairs at Olympus Medical Systems India Private Limited, your primary responsibility will be to oversee Indian regulatory affairs activities related to Gastrointestinal (GI) & Olympus products. You will also be responsible for advising and consulting with stakeholders about compliance with CDSCO, BIS, WPC, and other applicable regulatory bodies. Your role will involve implementing best practices and contributing to both the strategic and operational functions of the regulatory affairs team. Your key responsibilities will include assessing regulatory intelligence to assist in the development of local, regional, and global regulatory strategies. You will evaluate the regulatory environment and provide internal advice throughout the product lifecycle to ensure product compliance. Anticipating regulatory obstacles and emerging issues, you will develop solutions and identify requirements and potential obstacles for market access distribution. Furthermore, you will assist in the development of regulatory strategy, update strategy based upon regulatory changes and evaluate proposed products for regulatory classification and jurisdiction. You will determine requirements for regulatory submission, approval pathways, and compliance activities while providing regulatory information and guidance for product development and planning. In addition, you will compare regulatory outcomes with initial product concepts, negotiate with regulatory authorities, and identify the need for new regulatory procedures. You will help train stakeholders on current and new regulatory requirements, provide regulatory input on global regulatory requirements to product development teams, and advise stakeholders of regulatory requirements for quality, preclinical, and clinical data. You will also be responsible for assessing the acceptability of quality, preclinical, and clinical documents for submission filing, evaluating proposed changes for regulatory filing solutions, and monitoring the progress of the regulatory authority review process. Communication and interaction with regulatory authorities before and during the development and review of regulatory submissions will be crucial aspects of your role. To be considered for this position, you are required to have a qualification of M. Pharma/B Pharma along with a PG Diploma in Drug Regulatory Affairs. The preferred experience includes 12 to 15 years of working experience in a customer-oriented position in an international organization. Proficiency in MS Office, particularly Excel, and fluency in oral and written communication in English are essential. Key competencies for this role include business acumen, customer focus (internal and external), execution excellence, domain expertise, effective communication, developing organizational talent, and team leadership. By applying your expertise and knowledge, you will play a vital role in ensuring regulatory compliance and contributing to the success of Olympus Medical Systems India's regulatory affairs team.,
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