15 Iso13485 Jobs

As the Head of Quality and Regulatory Compliance at the India Innovation Center (IIC) in Bangalore, India, you will play a crucial role in leading the Quality and Compliance Groups within the organization. Reporting to the Supervisor Director Quality and Compliance Critical Care, you will be an integral part of the leadership team at Getinge India. Your primary responsibility will be to ensure the effective establishment and maintenance of quality systems in the projects executed at IIC. You will be tasked with providing strategic leadership and management for the Quality Systems at the IIC, developing a competent and accountable Quality organization aligned with business objectives and compliance standards. Your role includes building a quality management system and fostering a quality culture at IIC, ensuring effective implementation and maintenance of the quality management system, and reporting on its performance to top management. Additionally, you will have the authority to act on behalf of top management during internal and external audits, manage quality audit functions, contribute to corrective and preventive action activities, and oversee the implementation of ISO13485 and MDSAP along with QSR. Stakeholder management and leading change will be of high importance in this role. Furthermore, you will serve as the divisional Management Representative, overseeing third-party quality systems inspections and audits, preparing audit responses, and working with cross-functional teams to ensure quality metrics align with corporate goals. Your ability to establish credibility, drive continuous improvement, manage departmental costs, and instill personal accountability for quality will be critical to the success of the organization. To qualify for this position, you must hold a Bachelor's degree in engineering or a Life Science related field, along with a minimum of 15 years of hands-on experience in Quality Assurance, preferably in the medical device industry. You should be capable of working from the ground up to build a quality system that exceeds global requirements and customer expectations, demonstrating a startup mindset and progressive leadership experience. Strong knowledge of FDA and EU regulatory compliance, Quality System Regulation, Quality System Inspection Technique Audits, as well as excellent communication, leadership, and interpersonal skills are essential for this role. You should also be proficient in MS Office applications and possess the ability to coach, develop, and motivate associates within the Quality Organization. If you are a dynamic leader with a proven track record in quality and regulatory compliance, capable of driving organizational excellence and continuous improvement, this role offers a unique opportunity to make a significant impact in a challenging and rewarding environment.,

Job Description Summary Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Impacts quality of own work and the work of others on the team. Focused on execution of standard enabling activities/provision of advice subject to policy and work routines within an enabling discipline. There may be some latitude to rearrange the sequence to complete task/duties based on changing situations. Job Description Roles and Responsibilities Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms. Broadening knowledge of theories, practices and procedures in own discipline to execute functional policy/strategy; still developing functional knowledge and skills. Basic understanding of key business drivers; uses this understanding to accomplish own work. Good understanding of how work of own team integrates with other teams and contributes to the area. May have some autonomy to make decisions within a defined framework. Resolves issues in situations that require good knowledge and judgment within established procedures. Consults more senior team members for issues outside of defined policy/parameters. A job at this level requires good interpersonal skills. For customer facing roles, develops strong customer relationships and serves as the interface between customer and GE. Explains technical information to others. Required Qualifications This role requires basic experience in the Quality & Healthcare Quality. Knowledge level is comparable to a Bachelor&aposs degree from an accredited university or college ( or a high school diploma with relevant experience). Minimum 2-3 years of experience in Software and IT tools Quality assurance Knowledge on Medical device regulations and standards not limited to ISO13485, FDA 21 CFR Part 11, 21 CFR 820 Experience in Change Management and Computerized system Validations Desired Characteristics Strong oral and written communication skills. Ability to document, plan, market, and execute programs. Strong Project management skills and interpersonal skills to manage and communicate along with cross-functional teams . Inclusion and Diversity GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and scale, and youll be surrounded by career opportunities in a culture that fosters care, collaboration and support Additional Information Relocation Assistance Provided: No Show more Show less

We are looking for a Sr. Product Owner to join our Program and Portfolio Team and work on our next-generation patient engagement and management solutions. At Philips Sleep and Respiratory Care, we aim to make people sleep and breathe easy through innovative sleep/respiratory therapy devices, patient interfaces and medical-grade artificial intelligence and cloud technology solutions. Our flagship product, the Care Orchestrator, DreamMapper, Sleepware, and MaskSelector solutions, are leading software for patient engagement and management solutions in the patient's sleep therapy journey. Our customer base spans to more than 65 countries globally and serve millions of patients. We are currently venturing into the next-generation solutions utilizing the state-of-the-art cloud platform, technology and AI to realize our customer and patient needs in the Sleep and respiratory care and at scale. Your role as a Sr. Product Owner at Philips Sleep and Respiratory Care business Enterprise Software category involves driving the next-generation enterprise software solution. You will collaborate closely with a team of Product Designers, architects, Software Developers, Product Management, Program Managers, and cross-functional teams to: - Develop a strong understanding of users and business needs by gathering insights and translating requirements flow down to Software and system requirements. - Collaborate with cross-functional teams to prioritize features and enhancements based on customer feedback and market trends. - Define user stories, acceptance criteria, and sprint goals to ensure successful delivery of product increments. - Contribute to the business strategy for the product lines and work with stakeholders to build the product backlog in line with the roadmap. You will be solving complex problems with cross-functional experts in engineering, design, quality, or regulatory aspects, providing functional and non-functional specifications for the product engineering team, and working closely with software teams towards grooming and implementing the roadmap backlog. You should have a strong affinity to business acumen, experience in shipped software solutions with Software and API monetization techniques, and systems thinking when looking at multiple systems interactions and the impact on the product functioning. In terms of technical expertise, you should be able to review and analyze requirements at the domain level, align architectural requirements with the development strategy and regulatory requirements, and have knowledge of SW design, cybersecurity, cloud systems, distributed systems, and microservice architecture. Experience in one or more computer languages including C/C++, Java, Python, or similar language is required, along with knowledge of technologies such as Kubernetes, REST, architecture across SaaS/PaaS/IaaS, and cloud deployment. Prior experience in the healthcare industry is highly desirable, with an understanding of systems engineering and various healthcare regulatory standards like FDA CFR part820, ISO13485, and others being a plus. The ideal candidate for this role should have more than 12 years of relevant experience as a Product Owner, with a background in shipping highly technical digital products ideally in a B2B or B2C environment. Strong exposure to cloud technology solutions is necessary, along with being fully autonomous and having mastered the ideation and development process. Curiosity, enjoyment in working in cross-functional teams, a strong interest in developing healthcare products, and a bachelor's degree in engineering or an equivalent discipline are required. If you are interested in making a significant impact in the healthcare industry and have the relevant experience, we encourage you to apply for this role at Philips Sleep and Respiratory Care.,

You will be responsible for Mechanical design in the field of Medical Devices, with a focus on Medical Device Design Controls, Design Verification, and Validation processes. A minimum of 3 to 5 years of relevant experience is required for this role. As a Sustaining Engineer, you will lead Change Qualification projects for medical devices, collaborating with a diverse Cross-Functional Team. Your tasks will include developing test protocols, ensuring the quality of deliverables, and managing risk through proactive identification and mitigation planning. Proficiency in DesignControl process for Medical Devices is essential, along with expertise in Mechanical Engineering basics. You should possess strong project management skills and the ability to work independently. Additionally, you must have excellent oral and written communication skills, with a particular emphasis on technical writing. Knowledge of ISO13485 standards is advantageous for this position. Proficiency in software tools such as SolidWorks, 2D design, Tolerance Stackup, and MS Word/Excel/PowerPoint is required. However, eligibility for the role is not solely based on software tool proficiency but also on your overall expertise and experience in the field. To apply for this role, you must hold a B.E/B.Tech or higher degree in Mechanical Engineering. Your role will involve collaborating with stakeholders to drive technical solutions and effectively communicate complex engineering concepts. You should be self-motivated, detail-oriented, and capable of applying statistical methods to problem-solving. The position is based in Chennai, and the walk-in interview is scheduled for 26th July at HCLTech Elcot Sez, Chennai. Interested candidates can send their CV to laveena.deenadayalan@hcltech.com with the subject line "Application for Design Verification Engineer - Chennai".,

Role & responsibilities Job Description/Roles & Responsibilities Job Summary Hardware Developer who is ready to lead the Hardware design team, work on new circuit design and developement for products that can cure complications in new-borns, especially who need assistance just after birth. Knowledge of microcontroller based hardware design, sensors relating to flow, temperature and good EMI/EMC compliance relating to medical devices is a must for this position. Responsibilities and Duties Technical collaboration between the cross functional team and the client. Compile and analyze customer requirements, work with the team to find solutions, and consolidate and analyze customer requirements. Mentor the team towards deliverables and maintain project timelines. Strong experience in design & development of Medical grade PCBs. Good understanding of design complying EMI- EMC testing as per medical device standards Understanding of risk management for medical devices Develop schematics and layouts as per design requirements and manufacturing feasibility. Developing Embedded Hardware (Electronics) Digital, Analog and Mixed Signal Processing Manage BOM with standard ECR/ECN processes Component selection and handle component suppliers and PCB Fabricators. Preferred candidate profile 8+ years Experience in Embedded circuits and Power design Experience in Altium or KiCAD or Circuit Studio is must Understanding of Embedded firmware and protocols Hardware debugging and analysis skills Good communication skills and analytical skills. Experience with medical standards IEC60601 is desirable Experience in EMI/EMC Compliance Good Understanding of ISO13485 for Medical Devices Email resume - banu.m@pmsind.com

As a Medical Mechanical Design Verification/Control Engineer at HCLTech in Chennai Shollinganallur, you will be joining a team that values innovation, growth, and impactful work. This is an opportunity to work on cutting-edge projects in SME and be a part of something transformative! The walk-in drive is scheduled for 21st July Saturday from 9AM to 2PM at HCLTech Elcot Sez, 602/3, 138, Medavakkam High Road, Sholinganallur, Chennai-600119. The position available is for Mechanical Design (Lead, Technical Lead /Sr Lead) with an experience requirement of 3-7 years. To be eligible for this role, you should have a B.E/B.Tech or higher education in Mechanical Engineering. Sustaining Engineers are expected to have experience in Medical Device Design Controls, Design Verification & Validation for 3 to 7 years. You should be adept with the Design Control process for Medical Devices and have led Change Qualification projects for medical devices, collaborating with multi-cultured CFT. Your responsibilities will include developing test protocols and test plans, ensuring the quality of deliverables, expertise in Mechanical Engineering basics, Risk Management, applying statistical methods to problem-solving, and driving solutions for technical issues. Additionally, you should be self-motivated, capable of working independently, possess strong project management skills, and have excellent oral and written communication skills including technical writing. Knowledge of ISO13485 would be an added advantage for this role. Proficiency in software tools such as SolidWorks, 2D Tolerance Stackup, MS Word/Excel/PowerPoint is required. Interested candidates can share their CV with Katherine Sylvia at Katherinesylvia.k@hcltech.com, including details such as Current Company, Current CTC, Expected CTC, Notice Period, and Location. Make sure to bring this call letter for the walk-in interview on 21st July.,

Responsibilities: Ensure product compliance with ISO standards through quality testing. Collaborate on design reviews and risk assessments. Develop test plans, execute tests, analyze results. Experience with FDA & ISO13485 & PCB design, CAD/CAE s/w.

Key Responsibilities: Administer document and record control systems, ensuring version control, traceability, timely reviews, and overall compliance. Perform and document software tool validations and revalidations, ensuring alignment with relevant standards. Support supplier selection and ongoing monitoring, including maintaining relevant documentation and ensuring supplier compliance. Monitor regulatory developments (e.g. AI Act, GDPR), assess gaps, and implement required changes in the QMS. Draft, revise, and maintain procedures and work instructions based on regulatory or process changes. Prepare input for periodic management reviews, including KPIs, audit outcomes, and improvement actions. Support internal audits and coordinate evidence collection and follow-up actions. Proactively identify and drive opportunities for quality improvement or operational efficiency. Qualifications: 3+ years of hands-on experience in a quality or compliance role within a regulated industry (medical devices, pharma, health tech, etc.). Strong working knowledge of at least one management system (e.g. ISO 13485, ISO 27001, or ISO 9001). Excellent English communication skills (written and verbal); all documentation and communication is in English. Experience with documentation systems, change management, and audit readiness. Comfortable working independently and taking initiative in a remote setup. Nice-to-Have Certifications (not required): ISO Lead Auditor (9001 / 13485 / 27001) Regulatory Affairs Certification (RAC) or similar Computer System Validation (CSV) training Key Competencies: Excellent written and verbal English communicates clearly and professionally with international clients, both in documentation and direct interactions. Strong ownership mindset – proactively identifies tasks, follows through independently, and flags issues without needing micromanagement. Regulatory awareness and adaptability – keeps up with evolving standards (e.g., ISO updates, AI Act, MDR/IVDR) and translates them into practical system improvements. Clear and concise technical writing – able to draft and revise SOPs, validation reports, and audit evidence to meet compliance requirements. Process improvement orientation – continuously looks for ways to streamline or strengthen compliance workflows. Effective remote collaboration – comfortable in asynchronous, cross-border work environments and knows when to escalate or ask for input. Hands-on tool proficiency – experienced with document control systems (EDMS), QMS platforms, and validation or audit tracking tools.

You will be responsible for embedded hardware design with a focus on digital circuits. Your key responsibilities will include: - Developing new hardware solutions from initial requirements through prototypes to production-ready. - Designing embedded circuits, including component selection, Spice simulation, control loop design, power supplies, signal integrity check, interface designs, protocol analysis, mechanical interference, thermal analysis, high-reliability, long availability, BOM management, etc. - Coordinating with Layout engineers for proper layout design inclusive of power supplies routing, signal integrity, thermal dissipation, clear documentation, etc. - Maintaining existing designs and developing new variants of existing products to add new features, deal with component end-of-life, etc. - Improving the performance of existing designs and fixing hardware bugs identified in current revisions. - Working collaboratively with fellow Hardware team members, Product Management, Software Engineering, and Manufacturing to produce reliable, standards-compliant, world-class products. - Creating, improving, and automating Bench test setups, debugging, and characterization of embedded boards, power supply switching regulators, signal and power integrity measurements for board characterization. - Data collection, jitter measurements, analysis to enable simulation correlation, test design, and automation. To be successful in this role, you must have the following qualifications and skills: - Circuit design and analysis skills for digital and mixed-signal circuits. - Design and analysis of R/L/C filters, OpAmp circuits, and data-converter circuits. - Excellent knowledge of micro-controller families such as Cypress, TI, ARM architecture. - Excellent knowledge of building network adapters for various protocols i.e., USB, BLE, WiFi. - Excellent knowledge of SOCs. - Understanding of signal integrity, noise factors, filtering, decoupling, thermal, etc. - Excellent problem-solving and debugging skills. - Experience using schematic and circuit analysis tools like Eagle, Cadence, Orcad, etc. - Familiarity with Circuit layout tools like PCB Editor, Allegro, etc. - Experience in developing firmware for microcontroller or microprocessor-based boards. - Design of power supply converters of all topologies. - Experience with DFMA cycle. - Excellent understanding of requirements for electronics and electric tests such as ESD, EMC/EMI. - Successful experience in shipping over 1000 units of designs done. - Experience in performing CE/UL certifications for the board and products. - Knowledge of BGA components, passive and active components. - Good understanding of testing and debugging techniques. - Good understanding of revision control systems like SVN, GIT. - Experience with design from scratch with a product mindset and system-level understanding. - Experience in programming with medical sensors and/or biomedical device applications. - Working knowledge of ISO13485, ISO60601, ISO14971 guidelines. - Knowledge of MIPI, high-speed image signal processing. You will also enjoy the following perks and benefits: - Health insurance - Learning & development opportunities - Employee experience enhancements - 5-day work week pattern Role: Senior Associate Industry Type: Medtech Functional Area: Production, R&D Employment Type: Full Time, Permanent Education: UG: B.Tech/B.E. Electronics PG: MTech Embedded Systems,

Role & responsibilities Responsible for development, implementation, maintenance, and overall success of the companys quality and regulatory programs and strategies, including articulating quality standards and objectives, developing methods to embed quality into the product development and manufacturing processes, establishing vendor relationships and quality standards, and developing and implementing innovative programs to focus employees on improving product quality. Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements for our products and ensure alignment with our overall business strategy. Proactively partner with R&D, Marketing, and other groups to provide regulatory advice and guidance on meeting necessary requirements to place products on global markets. Ensure that regulated processes and systems are always inspection ready. Oversee the performance of internal and external audits. Review, edit, and maintain all departmental policies and procedures, including trainings, CAPAs, ECRs, and ECNs. Oversee the development of employees, talent, processes, and technology necessary to reach annual and long-term objectives as organizational leader for the QA/RA functions Serve as person responsible for regulatory compliance (PRRC). Other duties as assigned. Preferred candidate profile Extensive experience hosting regulatory inspections and interacting with regulators Strong understanding of global registration requirements and demonstrated track record of successful market access. Experience with computer software validation (CSV) and implementation for QMS and ERP software packages, including user requirements gathering and specification development, process workflow documentation, validation script writing, and IQ/OQ/PQ test case execution General understanding of ICH, cGMP, cGDP, FDA, ISO, MDR, Healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices Effective manager with ability to mentor and develop members of the QA/RA teams through coaching and effective performance management Proven ability to create culture of accountability and ownership Proven track record with establishing and maintaining strong internal and external partnerships. Must be able to work effectively at all levels in the organization in a matrix environment .and with external partners. Must demonstrate excellent written and verbal communication skills and work well with diverse teams and stakeholders in multiple locations. Must possess the ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities to meet deadlines and prioritize work on multiple projects. Highly independent and self-motivated and integrates well within a team. Physical Demands Ability to travel. Qualifications: Bachelors degree required in a science, engineering field or related discipline. MBA is a plus Experience: 10 years of QMS experience and demonstrated leadership experience. Proficiency with ISO 13485, Good Clinical Practices (GCP), and Quality System Inspection Techniques (QSIT); CFRs parts 210 &211.

JOB RESPONSIBILITIES OF PRODUCTION MANAGER Location: Delhi/ Faridabad Purpose of the Position :- The purpose of this position is to ensure that production planning , monitoring is done timely and executed efficiently. Ensure that proper documentation is maintained as per laid down SOPs / Regulatory requirements and ISO Guidelines Job responsibilities 1. Production Planning & Execution Develop and execute daily, weekly, and monthly production schedules. Ensure optimal resource allocation (manpower, machines, material). Coordinate with procurement, QA/QC, and warehouse teams. 2. Compliance & Quality Assurance Ensure production processes comply with ISO 13485, and regulatory requirements (e.g., MDR-2017). Maintain proper documentation (MFRs, SOPs, Batch Records). Participate in internal and external audits; support CAR (Corrections and Corrective Actions). To do the Risk Management of Production related processes. 3. Team Leadership & Training Supervise production team, including line operators and shift supervisors. Conduct training programs on hygiene, process controls, and SOPs. Monitor team performance, attendance, and shift efficiency. 4. Equipment & Facility Management Oversee maintenance and calibration of machines and equipments. Ensure readiness of controlled environments. Support validation activities (IQ, OQ, PQ) for equipment and processes. 5. Inventory & Material Handling Monitor raw material consumption and work-in-progress (WIP) inventory. Ensure traceability and control of critical components and lot numbers. Coordinate with stores for timely availability of materials. 6. Process Improvement & Lean Manufacturing Identify and implement process improvements for efficiency, waste reduction, and cost savings. Use lean tools like 5S and root cause analysis. 7. Documentation & Reporting Maintain accurate production records, reports, and logs and ensure good documentation practices are followed. Track KPIs such as OEE, yield, rejection rate, and downtime. Report production issues, deviations, and incidents to management. 8. Safety & Hygiene Ensure compliance with EHS (Environment, Health & Safety) policies. Implement workplace safety measures and incident response procedures. Conduct regular audits and hygiene checks. 9. Regulatory & Audit Readiness Keep the production area audit-ready for regulatory inspections (Notified Body, CDSCO). Support documentation review, observations response, and implementation of audit findings. 10. Any other task assigned by reporting Manager. The Job responsibilities may be revised as per company requirements as and when required.

Role & responsibilities QA Documents Preparation, review, & revision (such as Work Instructions, Flowcharts, SOPs, Inward Quality Plan, Technical Data Sheet, Formats, etc.) Document Control (Soft copy & Hard copy) Coordinate with QC, Production, Design team & management. Maintain master copy & distribute control copy of documents to respective departments. Gain knowledge regarding medical device applications. Developing and implementing quality systems: Including policies, procedures, and guidelines, to ensure that products or services meet the required quality standards. Conducting audits and monitoring processes to ensure that they comply with quality systems and standards. Handling Customer Complaints Handling Corrective Action & Preventive Action (CAPA). Suggest & implement new document/ process/ system. Preferred candidate profile Should be a Graduate of Biological Science. (Bsc & Btech Biotechnology) Minimum 1 to 2 years of relevant experience required Certified internal auditor for ISO 13485;2016. Experience working with 3D printers in the healthcare segment. Strong organisational skills that reflect the ability to perform and prioritise multiple tasks seamlessly with excellent attention to detail.

Job Description Job title: Quality Engineer, Products and Systems Your role: Be part of Project team and participate in defining product design input, requirements, V&V, output and design transfer requirements and plans. Ensure product quality, compliance and state of art throughout the product lifecycle. Reaffirm that design input are transferred to product design and verified to confirm that design output meet the design input. In collaboration with multi-disciplinary team, lead the design for reliability to create a reliability plan and include the reliability requirements in product design. Ensure that reliability requirements are met through test, verification and validations, as applicable. A distinguished champion on patient safety and quality with expertise on quality and compliance principles like IEC60601, IEC 62304, IEC62366, 21CFR806. You will be acting as subject matter expert to provide guidance on product design quality, safety, reliability, serviceability, maintainability, manufacturability and other aspect in collaboration with business and technical SMEs. Well conversant with QMS requirements in accordance with ISO13485:2016 and ISO14971. Expert in medical device risk management principles including risk evaluation, assessment, risk determination, mitigation and risk benefit analysis. You will be acting as facilitator for risk management activities in accordance with ISO14971 and other applicable regulatory requirements. You're the right fit if: (4 x bullets max) Experience: 12 to 20 Years, minimum 10 years in Medical device industry. Bachelor's in engineering or quality management, with 12 to 20 Years, minimum 10 years in Medical device industry. Proven knowledge of the FDA regulations for Design Controls for medical devices is a must and the combination with (extensive) experience with regulatory inspections has a very strong preference. Product Quality Engineering and Design Control experience is a requirement. Certification in Software Quality Engineering (CSQE) from ASQ or other bodies is desirable In-depth knowledge and a proven track record in implementing and applying concepts in the fields of designing in quality, reliability and problem-solving techniques have a strong preference. Leadership experience and good change management and influencing skills (required) You are Customer, Patient Safety and Quality focused. Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR. Advanced level knowledge of IEC62304, IEC62366 and ISO14971 has a strong preference. Excellent communication skills, able to clearly and concisely summarize complex technical problems You combine analytical and conceptual thinking, physical insight, system view, flexibility and a Handson mentality to deliver sustainable results and creative solutions. You are a motivated self-propelling person, with determination to succeed and the ability to manage change. Excellent organizational skills to lead and track deliverables Strong influencing skills power of persuasion, perseverance, getting things done mentality. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the companyu2019s facilities. Field roles are most effectively done outside of the companyu2019s main facilities, generally at the customersu2019 or suppliersu2019 locations. Indicate if this role is an office/field/onsite role. 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. u2022 Learn more about . u2022 Discover . u2022 Learn more about . If youu2019re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .

#Hiring Regulatory Affairs Manager for one of the reputed MNC into Healthcare industry. Position Title: Regulatory Affairs Manager Location: Gurugram About Role:- The Regulatory Affairs Manager will be responsible for managing the regulatory strategy and ensuring the compliance of medical devices/IVD with applicable regulations. The candidate should have relevant years of experience in Regulatory Affairs. Preferably, complete knowledge of Indian Regulatory Requirements with in-depth understanding of D&C Act, MDR 2017& BIS. This role involves working closely with cross functional team. The manager will monitor regulatory changes, support product submissions, and ensure timely approvals to maintain product marketability in India. Key Accountabilities:- Provide Regulatory Support for timely new product launches. Well versed with filing application of Import Registration/Import license/Test License on SUGAM portal and NSWS & BIS Regulations & Certification. Stay abreast of regulatory procedures and changes in regulatory climate. Responsible for managing BIS application and submission procedures To review Medical Device dossier and technical documents to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents and take appropriate actions to obtain regulatory approvals as planned. Address queries from CDSCO/NSWS on submitted applications, provide regulatory support and assist in preparing a response to regulatory authoritys questions within assigned timelines. Responsible for managing modifications to a device after it has received regulatory approval. Work with other departments and communicate the submission requirements when documents are needed for regulatory submission. Timely tracking and reconciliation of routine submissions/activities/Query response Post-Market Surveillance: Manage post-market surveillance activities, including adverse event reporting, field safety corrective actions, and vigilance reporting. Minimum Knowledge & Experience required for the position: Bachelor's/ Masters degree in a relevant field, such as life sciences, or regulatory affairs. Around 5+ years of relevant experience in Healthcare Industry (Medical Devices/IVDs) in Regulatory Affairs (MNCs) is desirable. Skills & Capabilities: Hands-on experience with the NSWS/ SUGAM portal and CDSCO online submission process. Strong understanding of Indian regulatory frameworks including CDSCO & BIS. Attention to detail and critical thinking skills Ability to work collaboratively with cross-functional teams. Note:- Looking Male candidate with decent exposure into RA role with reputed MNC's. If above role matches with your experience & aspirations than share CV to: recruit.corp12@apexservices.in

Role & responsibilities Product Industrialization Engineer - Medical Devices Knowledge on medical product life cycle management Should understand manufacturing fundamentals Responsible for PDLM-Driven design changes at manufacturing facility and at supplier Accountable for Manufacturing-BOM and routing master data until release to shipment and their implementation Accountable for establishing inspection and test criteria for components and assemblies Evaluate NPI related engineering changes To be responsible for Engineering Change Request activities. Supplier communication to create samples for NPD parts and verify supplier reports. Create new part numbers and do FAI plans based on drawings and Purchasing Spec. Interface between manufacturer and supplier for resolving doubts and issues. Coordinate with SQE to get necessary documents from supplier to complete APQP (IRF, IND, PSW, RSL). Knowledge In Label ad IFUs gap assessment activities. Manage PCN received from manufacturer to implementation. Manage & Document Supplier initiated change request. Create and update supplier data base in PLM. Ensure suppliers meet Drawing and Regulatory requirements. Being in a part of CFT team for supplier nonconforming material investigations. To succeed in this role, you should have the following skills and experience: Completed engineering studies at university level; BE/BTech in Mechanical, Electrical, Electronics, Biomedical Engineering or equivalent stream. 2-3 years of work experience in medical device manufacturing & supplier quality related background. Knowledge in ISO 13485, ISO 15223 & ISO 14971. Expert in GDP procedures. Experience in supplier communication, Engineering Change. Knowledge of Global Medical Quality and Regulatory Standards e.g. IEC, FDA, UL, CE etc. will be an added advantage. Disciplined team worker, ability to work independently. Ability to present and articulate ideas to key stakeholders and leadership team. Excellent communication skills. Quality mindset in design and documentation.