616 Mdr Jobs - Page 13

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Responsibilities may include the following and other duties may be assigned: Analyze returned products to identify failure modes and root causes. Conduct detailed assessments of device performance, including physical inspection and functional testing. Document investigation findings in the complaint handling system, ensuring accuracy and completeness. Review complaint data for trends and recurring issues. Identify opportunities for streamlining failure analysis workflows to improve efficiency and accuracy. Contribute to the development and implementation of standardized investigation procedures and tools. Support automation initiatives to reduce manual effort in complaint handling Ensure all complaint investigations comply with regulatory requirements (e.g., MDR, FDA). Maintain detailed and accurate records for audits and inspections. Support internal and external audits by providing investigation data and process documentation. Serve as a subject matter expert (SME) for failure analysis techniques and tools. Stay updated on industry standards and best practices for complaint handling and failure analysis. Train and mentor junior team members in complaint investigation and analysis methods. Monitor and report on key performance indicators (KPIs) related to complaint handling (e.g., FTQ, OCT). Drive improvements to meet or exceed quality and timeliness targets. Required knowledge, experience & skills : Bachelors degree in Engineering, Science, or Technical Discipline required and Minimum of 4 to 8 years of quality systems experience. Strong communication skills, both oral and written. Ability to understand the functionality / intended use of complex medical devices Computer literate with skills in Word, Excel, Access, PowerPoint and database trending analysis Comfortable working with international and multi-cultural department and groups in different time zones Accurate and delivers quality work, with a sense of urgency. Ability to work well under pressure and maintain positive, enthusiastic attitude. Ability to work in a fast-paced environment .Eagerness to learn and expand responsibilities & accountability . Skills - Nice to have : Knowledge of medical devices, their development and quality control. Knowledge of FDA, MEDDEV, Canadian Regulations. Technical Writing experience. Good interpersonal skills. Ability to work effectively in a team environment and build strong working relationships. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here

Role Objective: A key objective of this profile is to ensure the effective planning, execution, and documentation of validation and calibration activities, in compliance with regulatory standards and internal policies. The role focuses on maintaining high-quality standards, managing internal and external audits, and ensuring adherence to ISO 13485 and other relevant quality management standards. Additionally, the role supports continuous quality improvement initiatives and ensures that validation activities align with business needs and regulatory requirements. Desired Candidate Profile: Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field. A minimum of 6 years of experience in Quality Assurance within the medical device or pharmaceutical industry. Strong knowledge of validation processes, quality systems, and regulatory standards, such as MDD 93/42/EEC and ISO13485. Experience managing CAPA (Corrective and Preventive Action), conducting risk assessments, and handling internal/external audits. Proven ability to manage validation projects, including scheduling and team coordination. Excellent communication, organizational, and analytical skills. Role & Responsibilities: Plan and execute validation and calibration activities according to the approved schedule, including HVAC, process, transport, sterilization, equipment qualification, and temperature mapping. Coordinate the preparation of PR, PO, material issuance, and service entries for validation-related activities. Provide training to relevant personnel on validation processes and artwork review. Review and compile validation reports from external agencies, ensuring timely approval and payment processing. Verify vendor agreements and certifications, ensuring timely renewals and regulatory compliance. Oversee and ensure the proper execution of QMS activities, including document management and software use (e.g., TrackWise). Participate in line clearance and IPQA (In-Process Quality Assurance) activities as needed. Prepare and review GMP (Good Manufacturing Practice) documents such as SOPs, protocols, and other required documents. Ensure adherence to ISO13485 standards and other relevant regulations. Collaborate with the regulatory department to provide validation and calibration documents as needed for regulatory submissions. Participate in internal and external audits, ensuring timely and accurate documentation submission. Manage PR initiation and closure in TrackWise for qualification and calibration activities. Prepare and execute equipment and utility validation documents as per schedule. Functional Skills Required Expertise in Quality Management Systems (QMS) and validation processes. In-depth knowledge of MDR and other relevant regulatory frameworks. Strong proficiency in CAPA management, auditing, and risk assessment. Technical expertise in process, equipment, and product validation. Ability to manage multiple validation projects and meet strict deadlines. Behavioral Skills Required Strong team management and leadership abilities. Excellent problem-solving and analytical skills. High attention to detail and a commitment to accuracy. Strong interpersonal and communication skills. Ability to collaborate effectively across teams and departments. A proactive approach to continuous improvement and maintaining high-quality standards. Team Size to be Handle: Manage the team of 2-3 team members of Validation & QMS, reporting to AGM-QA. Learn more at: https://www.biotechhealthcare.com Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.

Job Title Software Design Quality Engineer Job Description Job Title : Software Design Quality Engineer Job Description In this role, you have the opportunity to Lead on setting Quality and Reliability targets for IGT Systems medical software so that these innovative products deliver high quality and outstanding reliability to the lives they will improve. Next to setting targets, you use your expert Quality and Reliability engineering skills to provide coaching and support to the project team(s) and assure that those targets are achieved. This involves being a confident advisor on quality and reliability engineering topics. You are responsible for Ensure that appropriate project plan and quality plans are made that include all stages of the product’s lifecycle, targets and strategy for a robust software products development. Validates key design inputs including requirements, specifications, useability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy serviceability, sustainability, and costs. Provides effective oversight during the execution of the Quality Plan and any risk management activities, and of all design related activities during the lifecycle. Contribute during design and development to identify critical quality attributes (CTQ, CTS) and ensure that appropriate mitigations and design controls are applied to mitigate the risks. Facilitate design failure mode and effect analysis to identify failure modes early in the design and development process and apply design, manufacturing and inspections to mitigate the risks. Ensure with objective V&V evidences that design output meets the design input. Leading quality related problem solving with the cross functional teams Using post-market data for analytics and statistics to report on the product’s performance in the market (provide feedback to manufacturing, suppliers, or design teams) and initiate field actions when required. Act as a single point of contact (person assigned to) for project team(s); you’re responsible to ensure the product’s design quality related requirements/criteria are complete and meet the quality standards for every project milestone. Make substantial contribution to integrate reliability engineering activities with the medical device development activities. Effective oversight of project deliverables and provide quality input, including safety, efficacy, regulatory. Facilitate the product defect investigations and actions during defect management review meetings. Participate in audits and regulatory inspection as design quality SME and guide other cross-functional stakeholders on technical aspects and audit conduct. You are a part of You will be part of the global Philips Q&R organization and will be reporting within the Design Quality team for IGT-Systems. As member of this team, you contribute to our constant strive for further product quality improvements, so we continuously exceed both internal and external stakeholder expectations. To succeed in this role, you should have the following skills and experience We are looking for a self-motivated and skilled individual who continuously strives for excellence as a way of life, not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life for the billions of people, that Philips improves every year. Specific skill requirements for this role include: Bachelor’s engineering degree with 12 years / Master’s degree with 10+ years of experience; in Software Engineering, quality engineering, SW Quality- or Reliability Engineering role in the medical or aerospace industry. Software testing experience will be an added advantage Ability to define detailed software quality and reliability plans for new medical product developments to ensure those are safe, effective and reliable. Ability to contribute to Risk Management and lead FMEA activities for new products and assurance that control measures are translated in appropriate (critical) requirements. Strong exposure to application of Design Controls; ability to do thorough Design Reviews during new product development to ensure robust designs that further improve patient safety and product quality. Ability to partner with V&V teams to assure thorough Verification, Validation and Useability testing. Analyze development and field data for Product Safety, Quality and Reliability performances and areas for further improvements of Product design and related development processes. Well conversant with statistical data analysis, regression modeling, reliability growth assessment and other quality techniques Experience with adequate and accurate review of DHF and DMR documents. Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, IEC 62366, IEC 62304 and ISO 14971. Experience with working in multidisciplinary teams in a high-tech R&D environment. Effective interpersonal, written and oral communication skills expected. Ability and willingness to work onsite About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. How We Work At Philips Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart Our commitment to inclusion and diversity At Philips, we provide equal opportunities to all our employees and to all eligible applicants for employment in our company , irrespective of age, color, disability, nationality, race, religion, gender, sexual orientation (LGBTQ +), and all aspects that make individuals unique. Encouraging diversity and fostering inclusion are key to our mission of improving the lives of 2.5 billion people a year by 2030 through meaningful innovation. We have fair, transparent, and clear employee policies which promote diversity and equality, in accordance with currently applicable law. For, we believe that life is better when #youareyou. Our hybrid working model is defined in 3 ways: We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving. We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis. We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. Why should you join Philips? Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

Job Location : Chennai Relocation Bonus for Outstation Candidates as per company policy. We are accepting Job Applications : Please submit updated CV - Email : Lamiya.JA@quest-global.com;sunil.chandran@quest-global.com Senior / Firmware Architect - Medical Devices | 10 - 20 Years | Job Description Responsibilities include - Design and architect embedded software systems from concept to production. - Lead and mentor a team of embedded software engineers. - Develop and maintain embedded software architectures and design patterns. - Optimize software for performance, reliability, and power consumption. - Conduct code reviews and ensure compliance with industry standards and best practices. - Interface with hardware engineers to define system requirements and specifications. - Develop and execute testing and validation plans for embedded software. - Stay updated with the latest advancements in embedded systems and incorporate relevant technologies. - Document software design and development processes. - Guide and provide necessary support for embedded software development according to medical device compliance and regulations(FDA, EU-MDR primarily). - Adaptive to manage and co-ordinate cross functional demand during product development and maintenance. Skills & Qualifications - Bachelor's or Master’s degree in Computer Science, Software Engineering, Electronics Engineering, or a related field. - Embedded architect experience primarily medical device. (High preference for hemodialysis machine and Renal care device experience) - Knowledge in IEC 62304, IEC 60601, ISO 13485 based embedded development. - Medical devices experience who can write SRS and run the entire product design process. - Over 12 years of experience in embedded software development and architecture. - Proficiency in Embedded firmware using embedded C, C++, and assembly languages. - Extensive experience with real-time operating systems (RTOS) and embedded Linux. - Strong knowledge of microcontroller/microprocessor architectures. - Experience with communication protocols such as CAN, I2C, SPI, UART, USB, etc. - Excellent problem-solving and debugging skills. - Proven track record of leading and managing engineering teams. - Strong communication and documentation skills. - Professional certifications in embedded systems or software architecture are a plus. Preferred Skills: - Experience with hardware design and schematic review. - Knowledge of modern software development methodologies (Agile, Scrum). - Familiarity with version control systems such as Git. - Understanding of safety-critical systems and compliance standards. Differentiators o Experience in New Product Development(NPD) of medical devices. o Strong experience in Renal Care o Usability Analysis

Our Mission At Palo Alto Networks® everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. Our vision is a world where each day is safer and more secure than the one before. We are a company built on the foundation of challenging and disrupting the way things are done, and we’re looking for innovators who are as committed to shaping the future of cybersecurity as we are. Who We Are We take our mission of protecting the digital way of life seriously. We are relentless in protecting our customers and we believe that the unique ideas of every member of our team contributes to our collective success. Our values were crowdsourced by employees and are brought to life through each of us everyday - from disruptive innovation and collaboration, to execution. From showing up for each other with integrity to creating an environment where we all feel included. As a member of our team, you will be shaping the future of cybersecurity. We work fast, value ongoing learning, and we respect each employee as a unique individual. Knowing we all have different needs, our development and personal wellbeing programs are designed to give you choice in how you are supported. This includes our FLEXBenefits wellbeing spending account with over 1,000 eligible items selected by employees, our mental and financial health resources, and our personalized learning opportunities - just to name a few! At Palo Alto Networks, we believe in the power of collaboration and value in-person interactions. This is why our employees generally work full time from our office with flexibility offered where needed. This setup fosters casual conversations, problem-solving, and trusted relationships. Our goal is to create an environment where we all win with precision. Job Description Your Career We are seeking a driven problem solver to join our Unit 42 MDR team. Our team is responsible for customers internal security monitoring, threat hunting and incident response. As a MDR Analyst, we will rely on you to detect and respond to cyber incidents facing customers’ internal business. The ideal candidate is a quick learner and good communicator who will be able to follow established processes for analyzing threat alerts that fire from our Cortex XDR. The candidate should be a creative thinker who takes pride in solving tough problems. Your Impact Join a new emerging team who is going to be part of Palo Alto’s Unit 42, Working closely with global customers providing the best security in the market Own an incident lifecycle from outbreak to full remediation Provide critical feedback to the different product, research and engineering and threat hunting teams to help improve the products for the entire Palo Alto Networks’ customer base Work closely with Security Research, Threat Intelligence and Threat Hunting teams to remediate and detect new emerging threats This position requires flexibility to work primarily during morning and afternoon hours however, occasional night shifts may be required depending on business demands Qualifications Your Experience 3+ years of experience in a multi tiered SOC/IR is a must Experienced with Technologies such as EDR, SIEM, SOAR, FW A well established familiarity with attack trends and vectors Excellent written and oral communication skills in English Some degree of Malware Analysis or equivalent military experience - An advantage CEH / CompTIA CYSA+ certifications - An advantage Hands-on experience with Cortex XSOAR or Cortex XDR - An advantage Additional Information The Team The team you’ll lead helps protect customers by identifying the most sophisticated & stealthy attacks in their environment. The team does so by leveraging the Cortex product suite as well as unique tools, methodologies and techniques. Cortex provides enterprise-scale detection and response that runs on integrated endpoint, network and cloud data — reduce the noise and focus on real threats. This team works closely with the different product teams and helps improve each and every product by providing first-hand insights into how the product is used and how it can perform even better. Our Commitment We’re problem solvers that take risks and challenge cybersecurity’s status quo. It’s simple: we can’t accomplish our mission without diverse teams innovating, together. We are committed to providing reasonable accommodations for all qualified individuals with a disability. If you require assistance or accommodation due to a disability or special need, please contact us at accommodations@paloaltonetworks.com. Palo Alto Networks is an equal opportunity employer. We celebrate diversity in our workplace, and all qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or other legally protected characteristics. All your information will be kept confidential according to EEO guidelines.

Job Description Job Overview: The Principal Instrumentation & Controls Eng is responsible for interpreting internal or external business issues and recommending best practices. They will be tasked with solving complex Instrumentation & Controls-related problems and will work independently with minimal guidance. The Principal Instrumentation & Controls Eng may be responsible for leading functional teams or projects and is regarded as a specialist in the field of Instrumentation & Controls. As such, they must have in-depth expertise in Instrumentation & Controls as well as broad knowledge of the Instrumentation & Controls discipline within the Engineering function. Responsibilities Key Tasks and Responsibilities: Perform conceptual, FEED, and detailed analyses and design as per design basis, project specifications, design codes, and standards Apply in-depth skills and broad knowledge of the business to address complex problems and nonstandard situations Prepare clear and accurate detailed design calculations and analyses including design reports and - procedures Manage own time to meet objectives and (as Lead Engineer) forecast and plan resource requirements Clearly communicate and explain difficult concepts and persuade others to adopt a point of view When acting as Lead Engineer, in addition: Direct medium or large Engineering team as a Lead Engineer Lead the Discipline engineering design of the assigned work area and completed within the planned schedule and budget, in accordance with standards, MDR, and project-specific procedures and to a high professional standard Plan, organize, and direct all aspects of Discipline execution on the assigned project including scope, deliverables, schedule, and all manpower resources - agree allocations with the Discipline Manager Ensure interfaces and deliverables are clearly identified Maintain responsibility for progress and productivity, identifying any required corrective action Act as project representative for the Discipline during meetings with the Project Team, Customer discipline lead, and relevant agencies such as certifying authorities, auditors, third parties, etc Become fully familiar with the project scope of work, specifications, schedule, and all inter-discipline requirements, including identifying concerns as early as practicable and taking appropriate initiatives to address the issues Interpret contractual requirements as they relate to engineering execution Identify changes to scope and promptly raise change notifications, including providing any necessary supporting documentation and estimates Provide similar support for Variation Orders Interface with all disciplines to develop clash-free designs Interface with other departments to obtain input for Discipline designs and drawings Maintain close coordination with other engineering disciplines, Planning, Fabrication, Marine, and Project Management teams, as required Document substantive communications (communications that result in significant decisions or assignment of actions) and forward copies to the Discipline Lead Engineer and Discipline Manager Prepare estimates for bid proposals, including technical query reviews, execution statements, and manhour estimates, identifying software requirements and any other project-specific requirements Raise technical queries to obtain missing information, clarify work scope, and maintain preferred McDermott procedures, specifications, standards, practices, and operational requirements Prepare, review, and (as Lead Engineer) approve Discipline engineering design basis, philosophies, and technical specifications Participate in finalizing deliverables lists and deliverables, ensuring compliance with specifications and functional integrity Review project schedule and fabrication schedule about construction sequence, milestones, and engineering scope Attend project kickoff and review meetings, vendor meetings, engineering meetings, and offshore site surveys, as required Provide technical direction and review of Designers producing products related to Instrumentation and Controls Engineering Prepare, review, and (as Lead Engineer) approve design reports and procedures Assist in providing necessary design inputs to other disciplines to enable them to proceed with their deliverables Assist procurement personnel in procuring Discipline equipment, materials, and services; ensuring that work produced complies with Customer objectives and procedures; procurement assistance includes preparing, reviewing, and (as Lead Engineer) approving requisitions, evaluating technical quotations, preparing queries, compiling bid tabulations and recommendations, preparing purchase requisitions, and coordinating with Procurement to expedite vendor documents, as directed by the Discipline Lead Engineer Assist in updating weight reports based on receipt of vendor information Review and (as Lead Engineer) approve vendor and subcontractor submittals, checking for compliance with project specifications and providing comments as necessary Review and (as Lead Engineer) approve design verification through single-discipline check / inter-discipline check (IDC) Provide technical support to fabrication queries, including identifying defect/rectification requirements Keep the Discipline Manager and Project Management Team apprised of all activities and concerns, technical, budgetary, and manpower related Assist in providing inputs for actual, planning, and forecasting progress reports including associated productivity Check final subcontractor and vendor data manuals to ensure that all requested data has been received and approved Present issues and problems to Customers in а timely manner and assist the Lead Engineer in negotiating resolution by project and company requirement Perform (as required) Technical Quality Audit reviews by MDR Global Procedures Assist Lead Engineer with responses to Customers and other agencies (such as certifying authorities, auditors, third parties, etc.) on their review and approval Capture lessons learned and entered them into MDR's Lessons Learned system Guide less experienced engineers on MDR and Discipline procedures, standards, worksheets, design calculations, software, requisitions, technical bid evaluations, technical queries, etc. Supervise and guide assigned engineers and coordinate with project Lead Designers for Discipline engineering and design deliverables Responsible for the engineering integrity of the assigned work area Monitor costs of own work processes Assist in the maintenance of departmental technical guidelines and standard calculation notes Participate in the development and maintenance of Global Procedures, Software, and Standards May participate in standards development committees or task groups such as API Develop communication and presentation skills (e.g., write technical papers, participate in conferences and/or seminars, present design solutions, and/or present topics at "lunch and learns"; etc.) Identify and provide training to staff in specific techniques and proprietary software Provide information on employee performance to the Discipline Manager Assist the Discipline manager in interviewing job applicants Prepare, review, and (as Lead Engineer) approve automation system definition, including philosophy, specifications, safety drawings, and system architecture Prepare, review, and (as Lead Engineer) approve ESD logic (as applicable) / cause & effect diagrams and F&G logic (as applicable) / cause & effect diagrams Review and (as Lead Engineer) approve specifications and data sheets for Instrumentation & Controls equipment Review and (as Lead Engineer) approve I&C equipment spare parts lists Review and (as Lead Engineer) approve inputs to P&ID development and markups based on receipt of vendor information Review and (as Lead Engineer) approve I&C equipment testing procedures Attend I&C equipment FATs, as required Participate in HAZOP, SIL, and Classification Studies, as required Assist in closing out HAZOP action items Provide construction, pre-commissioning, and commissioning support, as required Participate in automation testing, as required When acting as Lead Engineer, in addition: Act as project-based Discipline point of contact in communications and meetings with Customer counterparts Ensure substantive communications are documented Prepare bids and project Discipline engineering budget and execution plans, updating as required Identify project staff needs based on knowledge of individual engineer's skill sets and provide requests to the Discipline manager Plan, organize, and assign tasks, responsibilities, and manhour budgets to the discipline team, and verify tasks are completed within budgets Plan Discipline Level 4 detail deliverable schedule/ register compliant with the overall execution plan Prepare working forecasts identifying change management plans, corrective action, and real-time schedules Provide Discipline inputs for actual, planning, and forecasting progress reports including associated productivity Alert the project team of any deviation from the scope or а need for a change order Monitor КРI measurement results and take corrective action as necessary to improve Discipline performance, including performance at interfaces with others Coordinate with other Discipline Lead Engineers and Designers to ensure timely receipt of necessary design inputs Review and approve requisitions, technical quotation evaluations and queries, compiled bid tabulations and recommendations, and purchase requisitions; and coordinate with Procurement to expedite vendor documents as required Lead the Discipline team during project audits (internal, Customer, and third-party technical audits) and Design Reviews Review comments from Customers & other agencies on documents and drawings produced by the team, and resolve and give guidance on their update and incorporation Assist the Discipline manager in the preparation of quarterly forecasts and manpower planning Anticipate project engineering needs and plan accordingly Coordinate with vendor for discipline-managed/procured items Assist the Discipline manager and Project Engineering Manager or Project Manager in the Performance Evaluation of project team members Reports to: Project: Lead Engineer, Project Engineering Manager, or Project Manage Functional: Supervising Engineer or Engineering Manager Liaise to: AII Engineering disciplines, Fabrication Group, Safety Department, Offshore Group, Project Management Team, Document Control, Project Planner, Project Cost Controller, QC, and Certification Group, Procurement Group, Subcontractors and Vendors, and Customers Supervises: Senior Instrumentation and Controls Engineers and Instrumentation and Controls Engineers Qualifications Essential Qualifications and Education: Bachelor’s Degree in Electrical, or Electronics and Instrumentation Engineering (Master’s Degree is preferred) 15-20 years of experience in oil and gas with major contractors or consultants predominantly performing detail design Preferably Registered Professional Engineer or member of a professional engineering society Detailed knowledge of design techniques and analysis methods, and detailed knowledge of the theory, content, and application of standards, codes, and guidelines as applicable Knowledgeable in project coordination and execution skills About Us Lutech Resources has over 25 years’ experience providing tailor made recruitment and integrated resource management to leading Engineering, Energy and Manufacturing sector companies worldwide. We set ourselves apart from others in the industry by building long term relationships with both our clients and candidates based on a mutual understanding of their targeted industry and a passion for excellence. With every engagement, our goal is to quickly place qualified talent with the best suited employer. We have a genuine understanding of candidates and clients’ needs. Along with a dynamic and effective service, we strive for positive outcomes for everyone, every time.

The Product Owner is responsible for the definition and delivery of a part of a product from a customer and market requirement point of view - regarding content, prioritization, quality, and customer excitement for a given cost and time frame. Responsible for a part of the product through the product life cycle from the definition to the phase-out. Provides the associated development teams with priorities and expertise regarding the product and ensures completeness and consistency of the derived requirements within the part of the product. Responsible for definition and delivery of a part of a product from a customer and market requirement point of view, working with one or several development teams. Internal Interactions: Product Line Manager, Product Manager, Project Manager, Quality Manager, Development Team (e.g. Scrum Master, System Analyst, Architect, Developers, Testers), Usability Engineer, other stakeholders (e.g. Business Units), SCM (Enabling) & Customer Service teams, Technical Writers, etc. External Interactions: Customers – Hospital Administrators, IT Administrators etc. What are my tasks? Elicit and collect stakeholder requests Define and prioritize Market Requirements Analyze Market Requirements (e.g. initiate and manage concepts for complex Market Requirements) Derive, prioritize, and communicate Software Requirements Create Software Requirement Specifications (i.e. problem part) Coach/support development team's questions and resolve conflict regarding features and requirements Analyze and decide complaints and bugs/charms Achieve commitments with and motivate development teams, assist development teams in attaining maximum effective sustainable pace for development Ensure quality by evaluating results of iterations and either approve/ accept or reject results based on DONEness criteria Support effort estimations of development teams Analyze change request entries and prioritize with other product backlog items Coordinate cross-feature-area development with peers to facilitate prioritized product development Deliver input for project management Support roll-out of the system, presentation, workshops, training for sales and engineering What do I need to know to qualify for this job? Qualification: A Bachelors / master’s degree in engineering and / or MCA or equivalent. Work Experience: 12 to 15 years. Desired Knowledge & Experience: Knowledge on medical product Infrastructure, deployment technologies and non-medical software development. Knowhow of Containers, Kubernetes, Dockers and other Containerization technologies. Strong experience in Virtual Appliances, centralized logging, DBs and cloud hosting of applications. Exposure to CI/CD pipeline. Healthcare market - Product knowhow and customer understanding Knowledge of Clinical Workflows and Healthcare IT, especially in the area of Radiology. Healthcare Industry standards like DICOM and IHE is desirable. Basic understanding of Legal regulations and standards applicable for medical devices, affecting safety aspects(i.e. FDA 21CFR820QSR, MDR, ISO 13485) Exposure to Agile methodology Good programming skills & should have worked for most of the time in software programming roles. Thorough experience in Requirements Engineering, Usability Engineering, Cyber Security and feature definition activities. Product Lifecycle Management & Software development cycle experience What experience do I need to have? Professional: Several years of experience in the medical device/ healthcare industry (e.g. as a Product Owner, System Engineer, System Analyst, Technology Lead, Architect etc.). Several years of experience in IT product or solution business and service topics. Project / Process: Several years of experience in requirements engineering and SW development. Ideally, IT integration experience. Experience in agile development projects, preferably in Product Owner role. Leadership: Experience with managing internationally staffed teams, management and balancing of different stakeholder expectations, management of product definitions. Ideally several years experience in technical leadership role and communicating direction and coaching others. Intercultural: Experience with international/intercultural teams, conduction of workshops with international development partners and customers. What else do I need to be strong at? Self driven and takes Initiatives Decision making skills Result orientation Self motivated and provides motivation and inspiration to the team Strong Analytical and Problem-Solving Skills. Strong team player and networking skills Strong written and oral communication skills. Strong interpersonal skills Strong customer focus

ABOUT S3V VASCULAR TECHNOLOGIES LIMITED S3V Vascular Technologies Limited is an ISO 13485 certified company involved in the development and manufacture of Neurovascular, Cardiovascular Medical devices and Critical Care products such as Clot Retrievers, Neuro Aspiration Catheters, Neuro Micro-catheters, Neuro Guide catheters, Drug Eluting Stents, PTCA Catheters and drug coated critical care catheters. S3V is setting up an integrated manufacturing facility in Chennai at the Medical Device Park, Oragadam for the manufacture of Neuro interventional and peripheral interventional devices. With a strong focus on innovation, clinical safety, and regulatory compliance, we are committed to delivering cutting-edge solutions for critical care. Our manufacturing facilities are designed to meet global standards, including ISO 13485, and we are actively pursuing certifications under EU MDR, US FDA, and CDSCO guidelines JOB SUMMARY The Head of Regulatory Affairs (RA) is responsible for developing and executing regulatory strategies to obtain and maintain product approvals and licenses in India (CDSCO), the European Union (CE marking under MDR), and the United States (FDA 21 CFR Part 820). The role ensures that all Class III medical devices in interventional neurology, cardiology, and peripheral applications meet all applicable regulatory requirements for global market access. KEY RESPONSIBILITIES · Develop and execute regulatory strategies for CE marking (under EU MDR), US FDA approvals (510(k)/PMA), and CDSCO manufacturing and marketing authorizations. · Ensure timely preparation, submission, and maintenance of regulatory dossiers including Technical Files, Design Dossiers, and Device Master Files. · Act as primary contact with regulatory authorities (CDSCO, Notified Bodies, US FDA) and manage communications during audits, inspections, and submissions. · Oversee the creation, maintenance, and submission of all regulatory documentation to ensure compliance with global regulations. · Support product development teams to ensure regulatory requirements are embedded throughout the product lifecycle. · Monitor changes in international regulatory requirements and provide guidance to internal teams on compliance impacts. · Coordinate with cross-functional teams including Quality, R&D, Manufacturing, and Clinical Affairs to support regulatory submissions. · Ensure timely renewals, variations, and post-market reporting (e.g., vigilance reporting, adverse event notifications). · Lead regulatory due diligence and risk assessments for new product development and changes. · Manage and mentor the RA team to build internal regulatory competency. · Prepare for and support audits by regulatory authorities and notified bodies. · Ensure regulatory labeling, claims, and promotional materials comply with applicable laws and regulations. EDUCATION & EXPERIENCE · Master’s degree in Pharmacy, Engineering, Life Sciences, or related field. · 10+ years of experience in regulatory affairs within the medical device industry, including Class III devices. · Proven experience in obtaining CE certification under EU MDR and US FDA approvals (510(k), PMA). · Familiarity with CDSCO regulatory processes including site and product registrations. · Strong knowledge of global regulatory frameworks (EU MDR, US FDA, ISO 13485, Indian MDR 2017). · Experience with technical documentation, risk management (ISO 14971), and clinical evaluation reporting. . Strong interpersonal and communication skills to interface with regulators and internal stakeholders. KEY SKILLS · Strategic regulatory planning · Expert knowledge of medical device regulations · Regulatory submissions and dossier compilation · Strong written and verbal communication · Cross-functional leadership and collaboration . Project management and attention to detail

This job is with Amazon, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Description Job Description: The primary objective of the SLP Specialist is to provide security services, investigation and asset protection in designated area of responsibility, assist in mitigating product loss, and maintain customer satisfaction in accordance with India Security and Loss Prevention guidelines and policies. The role is cross-functional and requires deep collaboration and influencing ability with stakeholders from business and corporate functions. SLP Specialist's day-to-day activities involve planning, organizing, coordinating, implementing and executing process and procedures laid down by the organization and the SLP function. Identify the MDR shrink aspects last mile stations, including delivery partners. Identify the potential pilferage opportunities and organized fraud and work closely with the concerned stakeholders to mitigate the causes of losses. Optimum utilization of the resources to ensure and maintain high quality and timely support to Business teams. Conduct risk assessment and process audit for the respective sites and work in accordance with the security policies and guidelines. Security Operation. Implementation & Follow-up of Loss Prevention Plan in MDR. Audits and Compliance Conducting the SLP audits & implement the SOPs Preparation of Documents for Internal & External Audits Surprise Check and reports Process Improvement & Loss Prevention Program Process Review, Gap analysis & Necessary Improvements Weekly, Monthly and Quarterly Assessment Loss Prevention Reporting feed backs from Internal and External Stakeholders Loss Prevention Analysis and Investigation Weekly loss trend analysis, Identifying the defeats and work of the loss input reduction Conduct Investigation by working closely with stakeholders' team and support functions in SLP related areas. Meeting the weekly Investigation targets and submission of reports. Basic Qualifications University degree level or equivalent through experience and professional certification. A minimum of 7-10 years in Security and Loss prevention role, law enforcement or security-related profession. Extensive and up to date knowledge of Shrink management and Data Analysis. Experience in managing or coordinating security investigations of complex nature. Knowledge of information security processes and systems. Experience in security auditing Preferred Qualifications Loss Prevention Experience Investigation/Security related Certifications. Emergency Response / Crisis Management Training & Development. Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you're applying in isn't listed, please contact your Recruiting Partner.

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY-Cyber Security-TDR Senior (OT Lead Analyst – L3) As part of our EY-cyber security team, who shall work as SME for OT/IOT security solutions. The opportunity We’re looking for Senior consultant with expertise in OT/IOT security solutions. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of a new service offering. Your Key Responsibilities Acting as a member of the security operation centre with specific responsibility for the Operational Technology (OT) cyber security Provide operational support for globally deployed enterprise deployment of OT network monitoring solution such as Nozomi, Claroty, Armis, DarkTrace, Azure Defender. Coordinates with operational team to assess the security of OT and Internet of Things (IoT) systems. Serves as the primary technical analyst and expert for the OT Network Monitoring service offering. Work directly with various organizational team(s) to help analyse OT & IoT network traffic patterns Leading and implementing improvements in cybersecurity threat monitoring, attack response methods, incident response plans and validation of physical security, IOT, and SCADA environments In coordination with the Cyber Security team and other structures, be able to respond to the CSIRT and associated emergency preparedness procedures Assist in the Development and improvement of the security incident response framework, including related standards and processes, and ensure effective implementation Develop, conduct, and participate in Cyber Incident Response exercises Confirm the rules and or configuration and policy settings that should apply on Security controls based on incidents and threat intelligence. Participate in OT security incident response through all phases. Conduct hunt for Indicators of Compromise (IOC) and APT Tactics, Techniques, and Procedures (TTP). Establish strong working relationships with manufacturing sites and related personnel to drive recommendations to improve the Cybersecurity posture. Skills And Attributes For Success Knowledge of a relevant OT Cyber Framework such as NIST 800-82 or ISA62443. Experience and expertise in control systems (ICS, SCADA, DCS, etc) and OT, IoT security – design, deployment and hardening Ability to provide rapid and concise summaries of complex OT situations In-depth knowledge and understanding of how to handle and respond to OT security incidents as part of a specialised incident response team Strong working knowledge and thorough understanding of Protective Monitoring, Vulnerability Monitoring, Threat Intelligence and Threat Hunting within OT data Knowledge and understanding of a wide variety of security technologies and processes Up-to-date knowledge of current exploit techniques, vulnerability disclosures, data breach incidents, and security analysis techniques, combined with the understanding of the potential OT impact on the security posture Working knowledge of cybersecurity policies and standards related to ICS/SCADA, OT/IoT Security solutions (e.g. Industrial IDS, Industrial Firewall etc) Knowledge and understanding of the OT world as related to different components such as HMI, PLC etc) Knowledge and understanding of tools used to protect industrial environment Understanding of IT/OT/IoT communication protocols e.g., TCP/IP, UDP, DNP3, Modbus, IEC 61850, OPC, OPC UA, PROFINET, BLE, Zigbee Experience supporting and troubleshooting industrial protocols such as OPC, Modbus TCP, HART, Foundation Fieldbus Understand and be hands on, able to work with a wide range of Cyber Security related toolsets, SIEM, EDR/MDR, Vulnerability management, Microsoft and Linux operating systems, Firewalls, Networks, Deception tech, UEBA, IDS/IPS to name a few Ability to work with minimal levels of supervision or oversight. Exposure to IOT/OT monitoring solutions (Claroty, Nozomi Networks, Armis, Azure Defender etc) Good knowledge and experience in Security Monitoring and Cyber Incident Response To qualify for the role, you must have B. Tech./ B.E/M.Tech/M.E with sound technical skills Strong command on verbal and written English language. Demonstrate both technical acumen and critical thinking abilities. Strong interpersonal and presentation skills. 8+ years’ overall experience in cyber security with minimum 4 years of Hands-on experience of operating/implementing OT/IOT Security solutions. Relevant certifications (Security +, CISSP, GCIA, GCIH, GMON, GICSP, GRID, GCCC etc) Ideally, you’ll also have People/Project management skills. What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY-Cyber Security-TDR Senior (OT Lead Analyst – L3) As part of our EY-cyber security team, who shall work as SME for OT/IOT security solutions. The opportunity We’re looking for Senior consultant with expertise in OT/IOT security solutions. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of a new service offering. Your Key Responsibilities Acting as a member of the security operation centre with specific responsibility for the Operational Technology (OT) cyber security Provide operational support for globally deployed enterprise deployment of OT network monitoring solution such as Nozomi, Claroty, Armis, DarkTrace, Azure Defender. Coordinates with operational team to assess the security of OT and Internet of Things (IoT) systems. Serves as the primary technical analyst and expert for the OT Network Monitoring service offering. Work directly with various organizational team(s) to help analyse OT & IoT network traffic patterns Leading and implementing improvements in cybersecurity threat monitoring, attack response methods, incident response plans and validation of physical security, IOT, and SCADA environments In coordination with the Cyber Security team and other structures, be able to respond to the CSIRT and associated emergency preparedness procedures Assist in the Development and improvement of the security incident response framework, including related standards and processes, and ensure effective implementation Develop, conduct, and participate in Cyber Incident Response exercises Confirm the rules and or configuration and policy settings that should apply on Security controls based on incidents and threat intelligence. Participate in OT security incident response through all phases. Conduct hunt for Indicators of Compromise (IOC) and APT Tactics, Techniques, and Procedures (TTP). Establish strong working relationships with manufacturing sites and related personnel to drive recommendations to improve the Cybersecurity posture. Skills And Attributes For Success Knowledge of a relevant OT Cyber Framework such as NIST 800-82 or ISA62443. Experience and expertise in control systems (ICS, SCADA, DCS, etc) and OT, IoT security – design, deployment and hardening Ability to provide rapid and concise summaries of complex OT situations In-depth knowledge and understanding of how to handle and respond to OT security incidents as part of a specialised incident response team Strong working knowledge and thorough understanding of Protective Monitoring, Vulnerability Monitoring, Threat Intelligence and Threat Hunting within OT data Knowledge and understanding of a wide variety of security technologies and processes Up-to-date knowledge of current exploit techniques, vulnerability disclosures, data breach incidents, and security analysis techniques, combined with the understanding of the potential OT impact on the security posture Working knowledge of cybersecurity policies and standards related to ICS/SCADA, OT/IoT Security solutions (e.g. Industrial IDS, Industrial Firewall etc) Knowledge and understanding of the OT world as related to different components such as HMI, PLC etc) Knowledge and understanding of tools used to protect industrial environment Understanding of IT/OT/IoT communication protocols e.g., TCP/IP, UDP, DNP3, Modbus, IEC 61850, OPC, OPC UA, PROFINET, BLE, Zigbee Experience supporting and troubleshooting industrial protocols such as OPC, Modbus TCP, HART, Foundation Fieldbus Understand and be hands on, able to work with a wide range of Cyber Security related toolsets, SIEM, EDR/MDR, Vulnerability management, Microsoft and Linux operating systems, Firewalls, Networks, Deception tech, UEBA, IDS/IPS to name a few Ability to work with minimal levels of supervision or oversight. Exposure to IOT/OT monitoring solutions (Claroty, Nozomi Networks, Armis, Azure Defender etc) Good knowledge and experience in Security Monitoring and Cyber Incident Response To qualify for the role, you must have B. Tech./ B.E/M.Tech/M.E with sound technical skills Strong command on verbal and written English language. Demonstrate both technical acumen and critical thinking abilities. Strong interpersonal and presentation skills. 8+ years’ overall experience in cyber security with minimum 4 years of Hands-on experience of operating/implementing OT/IOT Security solutions. Relevant certifications (Security +, CISSP, GCIA, GCIH, GMON, GICSP, GRID, GCCC etc) Ideally, you’ll also have People/Project management skills. What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life As a Principal Project Management Specialist, you will be a key member of the Medtronic Quality Engineering team responsible for maintaining the highest standards of product reliability and patient well-being across the Cranial and Spinal Technologies (CST) Operating Unit. CST provides a comprehensive portfolio of proven powerful technologies setting the highest standards of integrity and reliability in Cranial and Spinal care. Responsibilities may include the following and other duties may be assigned Responsible for planning, initiating, monitoring, tracking and/or prioritizing MEIC Quality engineering team's programs and facilitating successful, on-time and within budget execution. Sets clear direction and operating mechanisms for ensuring effective monitoring and reporting of performance and safety of commercialized products, ensuring ongoing compliance with regulatory standards. Support day to day activities for multiple work-stream teams through managing project plans, resourcing, status reporting, resolving issues, identifying project risks and accountability for deliverables across multiple entities. Establishes and monitors meaningful metrics for success. Responsible for project performance, risk management, administration, financial management, budgeting, capital planning, forecasting and issue resolution. Manage communication strategies with MEIC and applicable CST entity stakeholder(s) for appropriate mapping of training needs, knowledge transfers and prioritization of work for sustainable long term growth. Support continuous improvement efforts and drive associated change implementation strategies for the product or process being supported. Required Knowledge and Experience Familiarity with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant standards for ensuring compliance to regulatory requirements. Ability to collaborate across the matrix – update crossfunctional (and leadership) teams on project status or issues to the organization and providing training on relevant procedures and policies. Participating in audits (where applicable) and demonstrating the ability to effectively contribute as a team player in various roles, including contributor, subject matter expert, leader, and facilitator. Previous experience working in a cross-functional team environment. Develop templates and lead trainings based on quality system regulations, applicable standards and guidance. Working knowledge and experience with ISO 9001, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards. Good verbal and written communication skills Ability to influence others across the organization and/ or locations Hands-on experience with Quality Management Systems (Post market surveillance and reporting, complaint analysis, product acceptance and Design/ Change Control) Strong written, verbal and project management skills Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

As the Product Manager for the Cios Fit Platform, you will be the strategic and operational owner of a unique surgery product platform, which is the only one engineered and made in India in SHS. The Cios Fit is a value-segment medical imaging solution designed for intraoperative use across a range of clinical specialties, including orthopedics, surgery and urology. The product is exported from India to 30+ countries and developing the global footprint and expanding the product platform to new clinical applications is key for the success of the platform. You will lead the product strategy, define market and user requirements, drive execution in R&D and SCM aligned with business goals, clinical needs, and regulatory standards. Your focus will be on ensuring the Cios Fit Platform expands its footprint and features while maintaining outstanding image quality, usability, reliability, and it meet the needs of clinicians and healthcare providers worldwide. Key Responsibilities Own the end-to-end product lifecycle of the Cios Fit Platform, from market analysis and roadmap definition to launch and lifecycle management. Collaborate with R&D, UX, Clinical Affairs, Marketing, Regulatory Affairs, and Service to shape and deliver the product vision. Translate clinical and customer requirements into clear product specifications and priorities. Analyze market trends, customer feedback, and competitive landscape to inform product decisions. Define product positioning, value propositions, and key differentiators in collaboration with the marketing team. Monitor product performance and customer satisfaction to guide improvements and extensions. Support regulatory submissions, risk assessments, and documentation in alignment with medical device regulations (e.g., MDR, FDA, IEC 60601). Lead customer engagements, coordinate customer use tests, product launch events, KOL interviews, site visits, and product demonstrations to gather insights and build advocacy. Coordinate product launch planning, sales enablement, and training for global markets. Regular travelling to Europe, China and other countries is necessary. Qualifications Bachelor’s or Master’s degree in Engineering, Biomedical Engineering, Electrical Engineering, Medical Technology, or related field. 5+ years of experience in product management, ideally within the medical imaging or surgical technology industry. Strong understanding of imaging technologies (e.g., X-ray, fluoroscopy), surgical workflows, and clinical environments. Experience working in regulated medical device environments (MDR, FDA 510(k), ISO 13485). Proven track record of translating user needs into product solutions with measurable clinical and business impact. Excellent communication, leadership, and collaboration skills to work with global, cross-functional teams. Business-fluent English; additional languages are a plus.

Regulatory Engineer Date: 20 Jun 2025 Location: Bangalore Company: LTTS Job Description - Regulatory Affairs Specialist Support development, preparation, & submission of technical files & regulatory documentation, including 510(k) submissions, APAC regulatory submissions, US FDA and EU submissions, pre submissions, and product registration dossiers for Class I, II, & III medical devices, in compliance with FDA, EU MDR, regulatory requirements, ISO 13485, and global regulatory requirements. Managed documentation for manufacturing line transfer activities and quality assurance, including the preparation and submission of adverse event reports, product safety evaluations, and regulatory impact assessments related to onmarket product changes, in compliance with regulatory requirements and facilitated acquisition of approvals. Reviewed and approved product labels, promotional materials, & packaging, managed regulatory number updates, product management, and state manufacturing licenses, to ensure compliance with FDA and ISO 13485 requirements. and quality enhancement throughout the line transfer process. Managed regulatory operations, including planning, preparation, assembly, & review of regulatory submissions, maintained regulatory databases (including Sharepoint), managed document control systems for FDA filings & market entry processes. Support preparation of regulatory filings such as 510(k) and instrument/software submissions, supported product release processes, reviewed protocols & reports, and engineering drawings in alignment with FDA submission requirements, and managing clinical investigations. Collaborated with QMS teams, supported audits and ensured submissions comply with relevant quality systems regulations, and ensured alignment of regulatory processes regulatory approvals and global standards, including EU MDR, ISO 13485 and FDA and APAC standards. Support documentation for the proposed changes to products and manufacturing processes, managed modifications in technical files, regulatory databases, & distributed documents, ensuring regulatory submissions reflect these changes. Worked with cross-functional teams, including engineering, quality, and manufacturing, to support manufacturing line transfers, regulatory submissions, and product release activities. Support documentation including 510(k) and PMA applications, Technical Files, and filings for product approvals, clearances, registrations, and licenses, and handled changes to existing ones, utilized SAP for enterprise resource planning and regulatory compliance management. Supported risk management processes to identify, assess, and mitigate regulatory risks associated with product development, manufacturing, and commercialization activities. Supported to create and manage Technical Files in accordance with IVDR regulations, collaborating with international colleagues to establish design dossiers for new product development and design changes tailored to specific markets. Desired: Line transfer experience Experience 8-10 years in a regulated medical device environment Experience in APAC region regulatory policies

Engineer - Project Management Sri City, IND Engineer - Project Management Location: Sri City, Andhra Pradesh, India, 517 646 Company: Chart Industries Ensuring Chart’s success VRV Asia Pacific Pvt. Ltd!!!A CHART Industries Company. We are a US Multi-National Company, wedesignand fabricate state-of-the-art vacuum insulated cryogenic storage tanks for the distribution & storage of liquefied gases such as nitrogen, oxygen, argon, LNG (natural gas), hydrogen and other hydrocarbons for use in industrial, healthcare, electronics, food & energy. Our vision , "Providing engineered solutions to enable a better tomorrow” , embodies our commitment to innovation and sustainability. Every decision we make contributes to a safer, stronger, and more resilient future for our customers, our communities, and each of us. Our mission , "We connect our people, leading technologies, and global expertise to deliver innovative and sustainable solutions for our customers and the world around us" , focuses on using our strengths to achieve success. We bring together world-class talent, leading technologies, and unmatched global expertise to deliver innovative and sustainable solutions. The strength of our people, our partnerships, and our pursuit of excellence drives us forward. Our Values – The Foundation of Our Success: Our five values define how we work, how we collaborate, and how we grow: Safety Above All Here for Our Customers People Make the Difference Pursue Excellence Passion for Results What Will You Do? On receipt of new P.O, check all commercial terms & conditions and discuss withSalesTeam for corrections (if any) Coordinate with Planning & Finance for order approval Post Sale Order in SAP and issue Order confirmation tocustomer In case, if Down payment (DP) is pending fromcustomer, get Proforma invoice from Finance team and send it tocustomer. Follow-up with concernedsalesperson till receipt of DP. Follow up manufacturing of all orders except Engg. tanks and update concernedSalesPerson about delays (if any) Notifycustomerabout readiness of material. Send Proforma invoice tocustomer, if balance payment is agreed prior to dispatch and Follow-up with concernedSalesperson till payment receipt. Follow-up with internal logistics for dispatch. If transport is not in our scope, coordinate withcustomerand get their transporter details Get MDR from QC team and send it tocustomer. Inform courier details tocustomer. MaintainSales& Back Office documents as per ISO standard Prepare monthly reports onSales& O/I and circulate to allsalesteam Follow-up withSalesteam for their monthly report SendCustomersatisfaction questionnaire once every quarter and follow-up withcustomerfor response Recordcustomerresponse in an excel sheet and send analysis to QC team SupportSalesteam by providingsupporting documents from various teams of VRV AP for Vendor Registration (Online / Offline) Identify new tenders floated by Govt. Organizations / PSU in India and forward tender docs. To domesticSalesteam Location Sricity, Tada, Andhra Pradesh

Arni Medica is a leading medical device manufacturer specializing in contract manufacturing, new product development, and high-quality production of nephrology and healthcare products. Key Responsibilities Strategic Leadership: Assume leadership and full P & L responsibility for the respective group/verticals. Prepare annual budget and Track project budgets and timelines. Develop and execute strategic plans to achieve organizational objectives and growth targets. Align operational goals with the company’s vision and mission. Identify and evaluate new business opportunities, partnerships, and market trends. Operations Management: Oversee all aspects of operations, including production, supply chain, procurement, and logistics, ensuring efficiency and cost optimization. Monitor performance metrics and implement process improvements to meet production goals and maintain quality standards. Ensure smooth coordination between departments for seamless workflow and timely delivery of products. Statutory Compliance: Ensure full compliance with local, national, and international regulatory requirements, including ISO 13485, ISO 9001, MDR, and CDSCO regulations. Maintain up-to-date knowledge of statutory requirements (ESI, ePF, GST, PT, RBI, FCGPR and Customs-import/export) and implement necessary changes in processes or documentation. Manage licensing, certifications, and regulatory submissions in coordination with the Regulatory Affairs team. Quality Assurance and Control: Lead initiatives to maintain and enhance product quality standards. Oversee implementation and adherence to quality management systems (QMS) and handle internal and external audits. Drive continuous improvement programs for product and process quality. Tender Management: Manage the identification, preparation, and submission of tender applications to secure government and private contracts. Collaborate with finance and legal teams to ensure tenders are aligned with company policies and meet compliance requirements. Maintain relationships with tendering authorities and track tender statuses to capitalize on opportunities. Subsidy and Grant Applications: Oversee the preparation, documentation, and submission of subsidy and grant applications with relevant authorities. Stay updated on government schemes, financial incentives, and policies applicable to the medical device and healthcare sectors. Work closely with financial and legal teams to ensure timely and accurate filing of subsidy claims. Team Leadership and Development: Build, mentor, and manage high-performing cross-functional teams. Define clear roles, responsibilities, and performance metrics for employees. Conduct regular performance reviews and implement training programs to enhance team capabilities. Financial and Resource Management: Prepare and manage operational budgets, ensuring financial discipline and profitability. Monitor financial performance and implement corrective actions to achieve targets. Oversee procurement and inventory management to optimize costs and prevent shortages. Statutory and Legal Operations: Ensure adherence to labor laws, environmental regulations, and health and safety standards. Manage company compliance with statutory bodies, including tax filings, audits, and certifications. Collaborate with legal teams to handle contracts, agreements, and other legal matters. Project Management: Lead and manage critical projects from initiation to completion, ensuring timelines, budgets, and deliverables are met. Anticipate project risks and develop mitigation strategies. Foster collaboration among stakeholders to ensure successful project execution. Stakeholder Engagement: Build and maintain strong relationships with clients, regulatory authorities, and business partners. Represent the company in industry forums, client meetings, and conferences. Market Intelligence and Innovation: Monitor industry trends, competitive landscape, and emerging technologies. Provide strategic insights for product innovation and market expansion. Key Skills Strong leadership and operational management skills. Expertise in tender and subsidy management processes. In-depth knowledge of regulatory frameworks and statutory compliance. Proven expertise in managing production, supply chain, and quality functions. Excellent communication, negotiation, and interpersonal abilities. Proficiency in financial management, project planning, and ERP systems. Strong analytical and problem-solving skills with a focus on continuous improvement. Preferred Qualifications MBA or advanced degree in business administration or healthcare management. Hands-on experience in the medical device or pharmaceutical industry. Cleanroom Injection Moulding, Extrusion, joint assembly followed with ETO sterilization Certification in Lean Manufacturing, Six Sigma, or related methodologies is a plus.

Location: Sri City, Andhra Pradesh, India, 517 646 Company: Chart Industries Ensuring Chart’s success VRV Asia Pacific Pvt. Ltd!!!A CHART Industries Company. We are a US Multi-National Company, wedesignand fabricate state-of-the-art vacuum insulated cryogenic storage tanks for the distribution & storage of liquefied gases such as nitrogen, oxygen, argon, LNG (natural gas), hydrogen and other hydrocarbons for use in industrial, healthcare, electronics, food & energy. Our vision , "Providing engineered solutions to enable a better tomorrow” , embodies our commitment to innovation and sustainability. Every decision we make contributes to a safer, stronger, and more resilient future for our customers, our communities, and each of us. Our mission , "We connect our people, leading technologies, and global expertise to deliver innovative and sustainable solutions for our customers and the world around us" , focuses on using our strengths to achieve success. We bring together world-class talent, leading technologies, and unmatched global expertise to deliver innovative and sustainable solutions. The strength of our people, our partnerships, and our pursuit of excellence drives us forward. Our Values – The Foundation Of Our Success Our five values define how we work, how we collaborate, and how we grow: Safety Above All Here for Our Customers People Make the Difference Pursue Excellence Passion for Results What Will You Do? On receipt of new P.O, check all commercial terms & conditions and discuss withSalesTeam for corrections (if any) Coordinate with Planning & Finance for order approval Post Sale Order in SAP and issue Order confirmation tocustomer In case, if Down payment (DP) is pending fromcustomer, get Proforma invoice from Finance team and send it tocustomer. Follow-up with concernedsalesperson till receipt of DP. Follow up manufacturing of all orders except Engg. tanks and update concernedSalesPerson about delays (if any) Notifycustomerabout readiness of material. Send Proforma invoice tocustomer, if balance payment is agreed prior to dispatch and Follow-up with concernedSalesperson till payment receipt. Follow-up with internal logistics for dispatch. If transport is not in our scope, coordinate withcustomerand get their transporter details Get MDR from QC team and send it tocustomer. Inform courier details tocustomer. MaintainSales& Back Office documents as per ISO standard Prepare monthly reports onSales& O/I and circulate to allsalesteam Follow-up withSalesteam for their monthly report SendCustomersatisfaction questionnaire once every quarter and follow-up withcustomerfor response Recordcustomerresponse in an excel sheet and send analysis to QC team SupportSalesteam by providingsupporting documents from various teams of VRV AP for Vendor Registration (Online / Offline) Identify new tenders floated by Govt. Organizations / PSU in India and forward tender docs. To domesticSalesteam Location Sricity, Tada, Andhra Pradesh

It's fun to work in a company where people truly BELIEVE in what they're doing! Job Description Summary: As a cybersecurity engineer focused on cloud security with Rocket Software, you are part of a global, fast-paced IT organization with a primary mission to provide world class service to software development labs and internal departments ensuring our employees have secure access and communication systems to perform at the highest level. The successful candidate will be a highly technical individual with responsibility for the security of company data and workloads in public cloud infrastructure and SaaS platforms. This role will also provide guidance, advice, data and reports on their activities, results and remediations to address cyber risk in the cloud. Additional responsibilities include monitoring, analyzing, and resolving security incidences in a proactive way and assisting to support the security technologies that help to protect the company. As this is an opportunity to help build a world class security program in a dynamic work environment, the ideal candidate will be comfortable in a fast changing and fluid environment. Essential Duties and Responsibilities : Deploy, manage and maintain the enterprise cloud security technology stack Utilize a wide range of security capabilities including both native cloud tooling and 3rd party platforms such as CNAPP and CSPM solutions, network detection and response (NDR), vulnerability assessment and discovery, identity and access management (IAM), data protection solutions, key management (KMS), and event logging systems in order to build a layered defense approach to cloud environments Develop playbooks for incident response and best practices focused on cloud architectures and SaaS technologies In coordination with the CISO and other InfoSec teams, support the companywide program for secure cloud and SaaS services Coordinate with external security partners, such as managed detection and response (MDR) providers on critical security workflows and playbooks Function as a technical member of the cyber response team supporting the investigation and remediation of cyber events and incidents, red team/blue team/purple team and enterprise tabletop exercises Analyze, assess and test for cyber threats across enterprise clouds Protect Rocket customer and intellectual property (IP) data Develop and present reports that detail approach, analysis techniques, results and recommended remediations Required Qualifications: 4-6 years of experience securing public cloud infrastructure in AWS, Azure and GCP. Hands on experience with tools such as Wiz, Orca or Upwind Experience working with secure cloud networking, compute and data workloads, and serverless computing solutions and securing SaaS solutions Experience securing CI/CD cloud delivery pipelines Knowledge of secure cloud practices and frameworks, specifically in AWS, Azure and GCP Knowledge of secure cloud architecture and best practices such as AWS’s Well-Architected Framework Experience with scripting languages is a plus Knowledge of cloud incident response and experience with tabletop exercise and red/blue/purple team engagements is highly desirable Experience providing user guidance, documentation, and consultation Excellent troubleshooting skills, self-motivated, results-driven and well organized. Experience with explosive growth and variable requirements Experience with change and incident management processes Cloud Security certifications are desirable Information Security: Information security is everyone’s responsibility. A fundamental principle of information security at Rocket Software is that all individuals in the organization have a responsibility for the security and protection of company information and IT Resources over which they have control, according to their role. Diversity, Inclusion & Equity: At Rocket we are committed to an inclusive workplace environment, where every Rocketeer can thrive by bringing their full selves to work. Being a Rocketeer means you are part of our movement to continually drive inclusivity, diversity and equity in our workforce. Rocket Software Inc. is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Rocket Software Inc. is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Rocket is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please call: 781-577-4321 or send an email to people@rocketsoftware.com. We will make a determination on your request for reasonable accommodation on a case-by-case basis. If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

It's fun to work in a company where people truly BELIEVE in what they're doing! Job Description Summary: As a cybersecurity engineer focused on cloud security with Rocket Software, you are part of a global, fast-paced IT organization with a primary mission to provide world class service to software development labs and internal departments ensuring our employees have secure access and communication systems to perform at the highest level. The successful candidate will be a highly technical individual with responsibility for the security of company data and workloads in public cloud infrastructure and SaaS platforms. This role will also provide guidance, advice, data and reports on their activities, results and remediations to address cyber risk in the cloud. Additional responsibilities include monitoring, analyzing, and resolving security incidences in a proactive way and assisting to support the security technologies that help to protect the company. As this is an opportunity to help build a world class security program in a dynamic work environment, the ideal candidate will be comfortable in a fast changing and fluid environment. Essential Duties and Responsibilities : Deploy, manage and maintain the enterprise cloud security technology stack Utilize a wide range of security capabilities including both native cloud tooling and 3rd party platforms such as CNAPP and CSPM solutions, network detection and response (NDR), vulnerability assessment and discovery, identity and access management (IAM), data protection solutions, key management (KMS), and event logging systems in order to build a layered defense approach to cloud environments Develop playbooks for incident response and best practices focused on cloud architectures and SaaS technologies In coordination with the CISO and other InfoSec teams, support the companywide program for secure cloud and SaaS services Coordinate with external security partners, such as managed detection and response (MDR) providers on critical security workflows and playbooks Function as a technical member of the cyber response team supporting the investigation and remediation of cyber events and incidents, red team/blue team/purple team and enterprise tabletop exercises Analyze, assess and test for cyber threats across enterprise clouds Protect Rocket customer and intellectual property (IP) data Develop and present reports that detail approach, analysis techniques, results and recommended remediations Required Qualifications: 4-6 years of experience securing public cloud infrastructure in AWS, Azure and GCP. Hands on experience with tools such as Wiz, Orca or Upwind Experience working with secure cloud networking, compute and data workloads, and serverless computing solutions and securing SaaS solutions Experience securing CI/CD cloud delivery pipelines Knowledge of secure cloud practices and frameworks, specifically in AWS, Azure and GCP Knowledge of secure cloud architecture and best practices such as AWS’s Well-Architected Framework Experience with scripting languages is a plus Knowledge of cloud incident response and experience with tabletop exercise and red/blue/purple team engagements is highly desirable Experience providing user guidance, documentation, and consultation Excellent troubleshooting skills, self-motivated, results-driven and well organized. Experience with explosive growth and variable requirements Experience with change and incident management processes Cloud Security certifications are desirable Information Security: Information security is everyone’s responsibility. A fundamental principle of information security at Rocket Software is that all individuals in the organization have a responsibility for the security and protection of company information and IT Resources over which they have control, according to their role. Diversity, Inclusion & Equity: At Rocket we are committed to an inclusive workplace environment, where every Rocketeer can thrive by bringing their full selves to work. Being a Rocketeer means you are part of our movement to continually drive inclusivity, diversity and equity in our workforce. Rocket Software Inc. is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Rocket Software Inc. is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Rocket is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please call: 781-577-4321 or send an email to people@rocketsoftware.com. We will make a determination on your request for reasonable accommodation on a case-by-case basis. If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

It's fun to work in a company where people truly BELIEVE in what they're doing! Job Description Summary: As a cybersecurity engineer focused on cloud security with Rocket Software, you are part of a global, fast-paced IT organization with a primary mission to provide world class service to software development labs and internal departments ensuring our employees have secure access and communication systems to perform at the highest level. The successful candidate will be a highly technical individual with responsibility for the security of company data and workloads in public cloud infrastructure and SaaS platforms. This role will also provide guidance, advice, data and reports on their activities, results and remediations to address cyber risk in the cloud. Additional responsibilities include monitoring, analyzing, and resolving security incidences in a proactive way and assisting to support the security technologies that help to protect the company. As this is an opportunity to help build a world class security program in a dynamic work environment, the ideal candidate will be comfortable in a fast changing and fluid environment. Essential Duties and Responsibilities : Deploy, manage and maintain the enterprise cloud security technology stack Utilize a wide range of security capabilities including both native cloud tooling and 3rd party platforms such as CNAPP and CSPM solutions, network detection and response (NDR), vulnerability assessment and discovery, identity and access management (IAM), data protection solutions, key management (KMS), and event logging systems in order to build a layered defense approach to cloud environments Develop playbooks for incident response and best practices focused on cloud architectures and SaaS technologies In coordination with the CISO and other InfoSec teams, support the companywide program for secure cloud and SaaS services Coordinate with external security partners, such as managed detection and response (MDR) providers on critical security workflows and playbooks Function as a technical member of the cyber response team supporting the investigation and remediation of cyber events and incidents, red team/blue team/purple team and enterprise tabletop exercises Analyze, assess and test for cyber threats across enterprise clouds Protect Rocket customer and intellectual property (IP) data Develop and present reports that detail approach, analysis techniques, results and recommended remediations Required Qualifications: 4-6 years of experience securing public cloud infrastructure in AWS, Azure and GCP. Hands on experience with tools such as Wiz, Orca or Upwind Experience working with secure cloud networking, compute and data workloads, and serverless computing solutions and securing SaaS solutions Experience securing CI/CD cloud delivery pipelines Knowledge of secure cloud practices and frameworks, specifically in AWS, Azure and GCP Knowledge of secure cloud architecture and best practices such as AWS’s Well-Architected Framework Experience with scripting languages is a plus Knowledge of cloud incident response and experience with tabletop exercise and red/blue/purple team engagements is highly desirable Experience providing user guidance, documentation, and consultation Excellent troubleshooting skills, self-motivated, results-driven and well organized. Experience with explosive growth and variable requirements Experience with change and incident management processes Cloud Security certifications are desirable Information Security: Information security is everyone’s responsibility. A fundamental principle of information security at Rocket Software is that all individuals in the organization have a responsibility for the security and protection of company information and IT Resources over which they have control, according to their role. Diversity, Inclusion & Equity: At Rocket we are committed to an inclusive workplace environment, where every Rocketeer can thrive by bringing their full selves to work. Being a Rocketeer means you are part of our movement to continually drive inclusivity, diversity and equity in our workforce. Rocket Software Inc. is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Rocket Software Inc. is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Rocket is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please call: 781-577-4321 or send an email to people@rocketsoftware.com. We will make a determination on your request for reasonable accommodation on a case-by-case basis. If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

Job Description: Degree in mechanical engineering, electrical engineering, applied sciences or a related discipline; 10+ years of professional experience in medical device in Risk management , regulatory Quality systems EU MDR, US FDA and closely working R&D, Regulatory Affairs & design quality organizations Strong proven experience in simplifying/reviewing RMM,BRD, RMF, Trace matrix, DHFs, Design requirements, IFUs, Risk management , V&V activities etc. Expertise in interpreting & implementing various medical device standards and guidance's, such as IEC , ISO. Experience with systems for quality management, product development, and follow-up of procedures Knowledge and application of medical device QMS is required (e.g., ISO 13485, MDSAP, EU MDR, Risk Management etc.) Ensures that appropriate Quality Plans are made that include all stages product life cycle ,supports Quality Plan Validate key design inputs like : Usability, Reliability, Performance, Supportability, Manufacturability, Safety, Security, Privacy, Serviceability, Sustainability etc. Provides effective oversight of the execution of the Quality Plan, Risk Management activities, and all design related activities during the product/system life cycle Performs independent technical assessment on product quality performance and post-market product quality analysis Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required Act as a single point of contact (person assigned to project team) responsible t ensure that hardware design meets quality and compliance standards for every milestone etc.)

Analyze post-market surveillance data from global sources (e.g., MAUDE, FAERS, EUDAMED, internal complaint databases) to detect safety signals and evaluate adverse event trends. Organize and manage complex datasets using appropriate database systems and data structures. Develop dashboards, visualizations, and summary reports for internal and external stakeholders, including support for regulatory submissions. Collaborate with cross-functional teams including safety physicians, data scientists, and regulatory experts to evaluate post-market safety data. Maintain up-to-date knowledge of regulatory guidelines (e.g., FDA, MDR, ISO 14971) relevant to post-market safety and vigilance. Contribute to the development and improvement of safety signal detection methodologies and tools. Ensure adherence to data privacy, ethics, and compliance regulations in all analyses. Support and manage multiple projects simultaneously as per stakeholder requirements. ATTENTION: Current Alcon Employee/Contingent Worker If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.

Analyze post-market surveillance data from global sources (e.g., MAUDE, FAERS, EUDAMED, internal complaint databases) to detect safety signals and evaluate adverse event trends. Organize and manage complex datasets using appropriate database systems and data structures. Develop dashboards, visualizations, and summary reports for internal and external stakeholders, including support for regulatory submissions. Collaborate with cross-functional teams including safety physicians, data scientists, and regulatory experts to evaluate post-market safety data. Maintain up-to-date knowledge of regulatory guidelines (e.g., FDA, MDR, ISO 14971) relevant to post-market safety and vigilance. Contribute to the development and improvement of safety signal detection methodologies and tools. Ensure adherence to data privacy, ethics, and compliance regulations in all analyses. ATTENTION: Current Alcon Employee/Contingent Worker If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.

We are seeking a Senior Regulatory Affairs Executive with strong expertise in medical devices. The role involves handling end-to-end regulatory compliance, preparing and submitting dossiers, coordinating with CDSCO, managing product approvals, and ensuring adherence to medical device regulations. Candidate should have good knowledge of MDR, BIS, ISO 13485, and related certifications. Must be capable of independently handling regulatory processes. Key Responsibilities: Preparation & submission of regulatory filings for medical devices Coordination with regulatory authorities (CDSCO, BIS) Handling technical files, clinical data, and product dossiers Keeping up-to-date with regulatory changes Ensuring timely approvals & renewals Requirements: Graduate/Postgraduate in Science, Pharmacy, or related field Knowledge of Indian and international medical device regulations Strong documentation and communication skills Preference: Candidates with experience in Class A, B, C, or D devices approval process. Let me know if you want this customized for LinkedIn or any specific company style. CONTACT - NAINA@9999570297 Job Type: Full-time Pay: ₹35,000.00 - ₹45,000.00 per month Schedule: Day shift Work Location: In person

University degree or equivalent through experience and professional certification • A minimum of 7-10 years in Security and Loss prevention role, law enforcement or security-related profession • Extensive and up to date knowledge of Shrink Management and Data Analysis • Experience in managing or coordinating security investigations of complex nature • Knowledge of information security processes and systems • Experience in security auditing INSLP (Security & Loss Prevention) is hiring an SLP Specialist to support growth of the “SLP MDR Concessions Abuse Program” and help preventing losses via identification of abusive entity. The program is aimed at identifying and eliminating Concessions Abuse while preserving customer trust. The primary objective of the SLP Specialist is to provide security services, investigation and asset protection in designated area of responsibility, assist in mitigating product loss, and maintain customer satisfaction in accordance with INSLP guidelines and policies. The role is cross-functional and requires deep collaboration and influencing ability with stakeholders from business and corporate functions. SLP Specialist's day-to-day activities involve planning, organizing, coordinating, implementing and executing process and procedures laid down by the organization and the SLP function. As a part of the SLP MDR Concessions Abuse program, the SLP Specialist is required to deep dive into the Concessions request raised by customer, and conduct end-to-end investigation across customer, DA/network and seller to identify the abusive entity. SLP has outlined frameworks for investigation, and the SLP Specialist is bound to adhere to the investigation guidelines. Along with primarily supporting on Concessions investigations, the SLP Specialist will be required to provide on-ground intel useful in uncovering abuse MOs. In order to ensure network integrity, the SLP Specialist will be required to conduct risk assessment and process audit for the respective sites and work in accordance with the security policies and guidelines. Key job responsibilities Security Operation • Implementation and follow-up of Loss Prevention Plan in MDR Concessions Audits and Compliance • Conducting SLP audits and implementing SOPs • Surprise check and reports at LM (Last Mile) stations • Keeping the plans and SOPs updated • Periodical check of documentation • Adhering to SLAs defined for the SLP MDR Concessions Abuse Program Process Improvement and Loss Prevention • Process review, gap analysis and implementation of necessary improvements • Weekly, monthly and quarterly assessments • Loss prevention reporting • Working on feedbacks received from internal and external stakeholders • Follow up and completion of CAPA • Recommending loss prevention initiatives based on on-ground intel Loss Prevention Analysis and Investigation • Work closely with the SLP and CS teams to analyze the loss trends in MDR Concessions • Weekly loss trend analysis, identifying defects / abusive entities and working towards loss reduction • Conduct investigations by working closely with CS and support functions in SLP and Ops • Meeting the weekly investigation targets and submitting investigation reports • Sharing RCAs and PTG initiatives on shrink and unmet goals Loss Prevention experience Investigation/Security related certification Emergency Response / Crisis Management certification Training & Development experience Auditing and security investigations experience Exposure to MNC culture and dynamics Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you’re applying in isn’t listed, please contact your Recruiting Partner.