25 Eu Mdr Jobs

Summary Independent Project work less complexity, e.g. early phase projects. Lead or support smaller and less complex projects or support more complex projects with mentoring. Higher complex routine tasks e.g. failure investigations and deviation, change controls etc. Manage projects and processes to support departmental portfolio, projects and objectives according to agreed timelines and standards. Ensure that compliance with cGMP is maintained in TRD. About The Role Key Responsibilities Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility Write review, decide on approval and/or release of GMP-relevant deliverables and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables. Manage project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility. Support Project management functions as a project team member. Provide support to TRD line functions in GMP related topics as per area of responsibility. Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.). Manage a Design History File / Tech File portfolio of assigned Medical Device/ Drug Device Combination projects from Quality perspective and provide functional expertise in responsibility for medical devices and combination products in cross-functional project teams to assure cGMP Compliance with medical device specific regulations (ISO 13485:2016, EU MDR, 21 CFR 820 and 21 CFR Part 4) and internal Novartis standards for Medical Device development products under submission and Life Cycle Management activities. He/She ensures the quality specific tasks of a Design History File and follow-up including supporting medical device reporting to regulatory authorities. Monitoring, analysis, and reporting of GMP related KPIs as part of management reporting, Review QA agreements for Medical Device projects. Coordinate complaint investigations for Medical Device projects. Review of release documentation for medical device components. Support PMS activities for Medical Device projects. Support QMS and Audit (external and internal) activities Minimum Requirements Masters, Bachelor/Technician (> 5 years pharma) Fluent English required (oral & written) Good skills in site (local) language desired. Good knowledge of cGMP, working knowledge in technical development, production or QA. Sound scientific, technical and regulatory knowledge. Good organizational and decision-making skills. Good and proven ability to analyze and evaluate cGMP compliance. Commitment To Diversity And Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [HIDDEN TEXT] and let us know the nature of your request and your contact information. Please include the job requisition number in your message Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways well help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

Role & Responsibilities: Develop and author clinical evaluation deliverables such as Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS) plans/reports, Post-Market Clinical Follow-up (PMCF) plans/reports, and Summary of Safety and Clinical Performance (SSCP) reports, in strict compliance with EU MDR 2017/745 and relevant global regulatory standards. Critically evaluate and synthesize clinical evidence from various sources including clinical investigations, scientific literature, PMS/PMCF data, and registries. This includes reviewing medical literature, analysing clinical risks, and providing comprehensive benefit-risk assessments for medical devices. Collaborate cross-functionally with teams in Regulatory Affairs, R&D, Quality Assurance, Sales, and Marketing to ensure alignment on clinical evaluation project deliverables and support product development, approval, and post-market activities. Review and provide feedback on Instructions for Use (IFUs), patient guides, clinical study protocols, and clinical investigation reports to ensure consistency and compliance with regulatory requirements. Manage responses to regulatory authorities (e.g., Notified Bodies and Competent Authorities), addressing complex queries related to clinical evaluations and ensuring compliance with EU MDR and other regulatory frameworks. Ensure quality and integrity of documentation, maintaining attention to detail, consistency, and adherence to regulations such as ISO 13485, ISO 14155, MEDDEV 2.7/1 Rev 4, and EU MDR 2017/745. Support regulatory submissions by providing clinical evidence for product approvals, indication expansions, and ensuring compliance with post-market surveillance and clinical follow-up obligations. Stay current with global regulations and standards, including MDR, MEDDEV, and ISO, and effectively communicate the implications of evolving regulatory landscapes to internal stakeholders. Requirements: Advanced degree in life sciences, biomedical engineering, or a related medical/scientific discipline. 4 to 5 years of experience in clinical evaluation, medical writing, or a related role in the medical device industry, with a focus on clinical evaluation documentation Proven experience in medical writing, with a strong focus on clinical evaluation documentation for medical devices. In-depth knowledge of EU MDR 2017/745, MEDDEV 2.7/1 Rev 4, and relevant ISO standards (ISO 13485, ISO 14155). Excellent ability to critically appraise clinical data and present well-organized, scientifically sound reports. Strong technical and medical writing skills, with an ability to convey complex information clearly and concisely. Experience with regulatory submissions and addressing Notified Body/Competent Authority queries is a plus.

PMS Specialist Experience - 2-8 Years Location - Bangalore Key skills - PMS , EU MDR , Complaint Handling

Position: Production Head Experience: 10 To 20 Yrs Location: Bangalore Department: Manufacturing Industry: Medical Devices / Healthcare Technology Role Summary We are looking for an experienced and strategic Production Head to lead our manufacturing operations in the medical device domain. The ideal candidate will have deep knowledge of regulated production environments, strong people management skills, and a passion for driving quality, safety, and efficiency. This role is critical to ensuring that our products meet global standards and are delivered on time and within budget. Key Responsibilities Lead and oversee all daily manufacturing activities, ensuring production targets, timelines, and quality standards are met. Develop and implement effective production strategies aligned with company goals. Ensure full compliance with regulatory and quality standards, including ISO 13485, FDA21 CFR Part 820, and EU MDR. Manage cleanroom operations and ensure adherence to safety and hygiene protocols. Plan and optimize resource allocation including manpower, materials, and machines. Implement and promote Lean Manufacturing, 5S, Six Sigma, and other process improvement techniques. Coordinate with cross-functional teams such as Quality, R&D, Regulatory Affairs, SCM, and Maintenance. Oversee preventive and corrective maintenance of production equipment and ensure minimal downtime. Ensure documentation practices meet Good Manufacturing Practices (GMP), including DMR, DHR, CAPA, NCR, etc. Train, mentor, and lead the production team to drive productivity and accountability. Participate in internal, external, and regulatory audits. Qualifications Bachelors/Masters degree in Mechanical / Industrial / Biomedical Engineering or related field. Certifications in Lean, Six Sigma (Green/Black Belt), or ISO 13485 are an advantage. Experience 12-20 years of experience in manufacturing, with at least 5 years in the medical device or pharma industry. Prior leadership role in managing large-scale, regulated production lines. Key Competencies In-depth knowledge of regulatory standards (ISO 13485, GMP, FDA, EU MDR). Excellent team leadership, communication, and conflict-resolution skills. Proven track record in implementing continuous improvement and cost-saving initiatives. Hands-on experience with ERP/MES systems. Strong analytical and decision-making abilities. Why Join Us? Opportunity to lead in a fast-growing, innovation-driven organization Work on cutting-edge medical technologies that impact lives A culture that values quality, teamwork, and continuous learning

The candidate should be M.Sc. (Preferably Microbiology) / M.Pharm/Quality Assurance) with at least 10 /12 years of relevant experience in medical devices industry. IPQA, QMS, Validation, compliance , QA related to its processes and strategy.

Job Title: QARA ENGINEER Experience: 4.5 to 10 years Location: Bangalore Mandatory Skill: US FDA, 510K, PMA, EU MDR, QARA. Regulatory gap assessment and remediation. Job Description: The objective of this project is to identify and remediate any deficiencies in the design history files (DHF) and device master records (DMR) of the stent graft integrated with 4 branched vascular prosthesis - FROZENIX 4 Branched, ensuring adherence to relevant standards, US Food and Drug Administration ("FDA") guidelines and regulations requirements by completing all necessary tasks including document translation (Japanese to English), gap assessment, remediation and submission query support. Design verification and Validation US FDA 510k submission process US FDA Premarket approval ISO 14971 - Medical device risk management DHF Gap assessment DMR Gap assessment EU MDR 2017/745 regulations CE Technical documentation Technical standards and guidance (for medical device) ISO 60601 Electrical safety IEC 62304 - Human factors and Usability engineering ISO 10993 - Biocompatibility testing

PMS Plan/Report, PSUR (EU MDR), Complaint & Trend Analysis, Risk Assessment, Data Issue Resolution. EU MDR, ISO 14971, Complaint Trending, Risk Analysis, GDP, ISO 9001/13485, FDA 21 CFR 820/822, Cross-functional Coordination, Strong Organization.

Looking for candidates with 2–4 years of strong PMS experience in the medical device domain (preferably ortho/trauma). Must be skilled in EU MDR, PSUR, trend reports, risk assessment (ISO 14971), and complaint handling. Required Candidate profile Note: This role is exclusively for PMS professionals with hands-on experience in medical devices.

Role & Responsibilities Lead and support a team of globally located Product Assessors Conduct in-depth technical documentation reviews for Active Medical Devices Ensure compliance with EU medical device regulations and standards Collaborate with cross-functional teams to improve efficiency and service quality Monitor team performance, technical skills, KPIs, and wellbeing Handle recruitment, including CV review, interviews, and onboarding Develop and deliver technical training sessions internally and externally Provide expert support on technical and sales-related queries in Active Medical Devices Ensure top-tier service delivery within the SGS medical device certification network Preferred Candidate Profile Strong experience in Active Medical Devices or regulatory affairs Proven leadership and mentoring abilities Excellent communication and cross-functional collaboration skills Familiarity with EU MDR and quality compliance processes Experience in technical assessments and certification services

Proficient in EU MDR, ISO 14971 Risk Management, complaint trending, and GDP. Skilled in ISO 9001, ISO 13485, FDA 21 CFR 820/822. Strong team player with ability to prioritize, self-motivate, and ensure regulatory compliance

Prepare, review, file, and support premarket documents for global registrations for assigned projects. .Review pre-clinical, and clinical protocols and associated reports to be used. Collaborate with business unit and international regulatory affairs

Knowledge and Skills Working knowledge of 510(k) submissions, EU MDR 2017/745, MDSAP, EN ISO 13485, and 21 CFR 820 - Quality System.

Job Title: QMS Specialist # Salary: As per Industry Standards (Depend on Experience/Knowledge) # Job Summary: We are seeking a highly skilled and experienced QMS Specialist to join our team in the plastic molding industry. The successful candidate will be responsible for implementing, maintaining, and continuously improving our QMS, ensuring compliance with international standards and regulations. # Key Responsibilities: 1. Develop, implement, and maintain QMS in accordance with international standards (e.g., ISO 9001, IATF 16949). 2. Ensure compliance with regulatory requirements, industry standards, and customer-specific requirements. 3. Conduct internal audits to ensure the effectiveness of the QMS and identify areas for improvement. 4. Lead corrective action and continuous improvement initiatives to address quality issues and improve processes. 5. Develop and maintain quality-related documentation, including procedures, work instructions, and records. 6. Provide training and support to employees on QMS policies, procedures, and requirements. 7. Manage and analyse quality data, including customer complaints, internal rejects, and supplier performance. 8. Collaborate with cross-functional teams, including production, engineering, and procurement, to ensure quality requirements are met. 9. Maintain relationships with external parties, including customers, suppliers, and certification bodies. 10. Stay up-to-date with changes in regulations, standards, and industry best practices. # Requirements: 1. Bachelor's degree in a relevant field (e.g., QMS/BE/MBA). 2. Minimum 8 -10 years of experience in a QMS role, preferably in the plastic molding industry. 3. Certification in a recognized quality management standard (e.g., ISO 9001, IATF 16949). 4. Strong knowledge of quality management principles, including lean manufacturing, Six Sigma, and continuous improvement. 5. Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams. 6. Strong analytical and problem-solving skills, with the ability to interpret data and make informed decisions. 7. Proficient in Microsoft Office and quality management software. # Nice to Have: 1. Experience with industry-specific regulations and standards (e.g., FDA, EU MDR). 2. Certification in a related field (e.g., quality engineering, supply chain management). 3. Job Title: QMS Specialist # Salary: As per Industry Standards (Depend on Experience/Knowledge) # Job Summary: We are seeking a highly skilled and experienced QMS Specialist to join our team in the plastic molding industry. The successful candidate will be responsible for implementing, maintaining, and continuously improving our QMS, ensuring compliance with international standards and regulations. # Key Responsibilities: 1. Develop, implement, and maintain QMS in accordance with international standards (e.g., ISO 9001, IATF 16949). 2. Ensure compliance with regulatory requirements, industry standards, and customer-specific requirements. 3. Conduct internal audits to ensure the effectiveness of the QMS and identify areas for improvement. 4. Lead corrective action and continuous improvement initiatives to address quality issues and improve processes. 5. Develop and maintain quality-related documentation, including procedures, work instructions, and records. 6. Provide training and support to employees on QMS policies, procedures, and requirements. 7. Manage and analyse quality data, including customer complaints, internal rejects, and supplier performance. 8. Collaborate with cross-functional teams, including production, engineering, and procurement, to ensure quality requirements are met. 9. Maintain relationships with external parties, including customers, suppliers, and certification bodies. 10. Stay up-to-date with changes in regulations, standards, and industry best practices. # Requirements: 1. Bachelor's degree in a relevant field (e.g., QMS/BE/MBA). 2. Minimum 8 -10 years of experience in a QMS role, preferably in the plastic molding industry. 3. Certification in a recognized quality management standard (e.g., ISO 9001, IATF 16949). 4. Strong knowledge of quality management principles, including lean manufacturing, Six Sigma, and continuous improvement. 5. Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams. 6. Strong analytical and problem-solving skills, with the ability to interpret data and make informed decisions. 7. Proficient in Microsoft Office and quality management software. # Nice to Have: 1. E xperience with industry-specific regulations and standards (e.g., FDA, EU MDR). 2. Certification in a related field (e.g., quality engineering, supply chain management). 3. Experience with quality management software (e.g., QMS, EQMS)

Job Purpose: Maintain compliance to Quality Management System to deliver consistent quality medical devices to fulfil future strategy of Cipla. To Lead and establish Quality Management System for medical devices as per EU Regulatory requirements, CDSCO and ISO 13485 requirements and develop and implement documentation such as SOPs, Quality manual etc. to define the framework. Monitor effective implementation of Quality System across function and appraise Management Representative. Responsible for monitoring metrics/KPI for medical devices starting from design, manufacturing, postproduction. Compile data for management review meetings. Responsible for coordinating with cross functional team for internal / external audit compliance for ISO and CE marking Responsible for surveillance of regulatory guidance/ standards applicable to medical devices in the respective geographies in which Cipla products are distributed. Key Accountabilities: Develop, establish and maintain the QMS for medical devices according to EU MDR and ISO 13485 requirements. Surveillance of new/updated regulatory guidance/ ISO standards applicable to medical devices as per Ciplas product portfolio to ensure compliance to latest regulations. Surveillance of EU noncompliance reports / CDSCO / USFDA etc that are applicable to medical devices manufactured by Cipla to enable continuous improvement. Execution of Quality Management Review meeting for Medical devices and implementation of actions derived in the QMR meetings. Conduct audit of Vendors / contract manufacturers/ outsourced activities associated with medical device manufacturing/ servicing/ testing/ distribution. Ensure timely submission of quality documents to fulfil regulatory requirements. Major Activities / Tasks: Develop and establish Management responsibility system as per ISO 13485 and EU MDR Develop and establish design control system for EU market. Develop and establish key performance indicators (KPIs) for monitoring site performance and effectiveness of QMS as per ISO 13485. Prepare SOPs, Quality manual etc.as per ISO 13485/ EU MDR. Responsible to maintain compliance to ISO 13485 by adhering to SOPs and ensuring control and oversight over adherence by respective depts to SOPs. Periodic review of SOPs related to medical devices as per regulatory requirements and update. Arrange training and promote awareness among cross functional teams on ISO 13485 QMS and CE Marking Ensure readiness from QMS standpoint for internal and external audits. Provide guidance and support during internal and external audits examining compliance to EU MDR/ISO 13485 requirements. Co-ordinate with cross functional teams for internal/ external audit compliance. Create library of ISO standards. Review new/upcoming/ draft/ revised/ final regulatory guidance/ ISO standards related to medical devices applicable as per Ciplas product portfolio. Gap assessment of the guidance / standards in comparison to QMS at Cipla and identify suitable actions prior to implementation of the guidance/standard. Monitor implementation of the actions to enable continuous improvement. Schedule quality management review (QMR) meeting for medical devices. Collate data required for the QMR and prepare the presentation on site performance to monitor effectiveness of Quality management system. Appraise management representative regarding critical issues. Monitor implementation of the action plans derived from QMR by coordinating with other cross functional team. Audit of Vendors supplying Medical devices and Invitro diagnostic kits, completing audit documentation and verifying actions taken by the audited site to correct non-conformances observed. Audit of CMOs manufacturing medical devices, completing audit documentation, and verifying actions taken by the audited site to correct non-conformances observed. Audit of outsourced activities related to medical devices manufacturing/ servicing/ testing/ distribution. Coordinate with RA, QA team and Pharmaco vigilance team through emails and phone to enable timely submission of the documents. Major Challenges: Establishing Quality Management System for Medical devices according to EU MDR / ISO 13485 is new for Cipla, hence developing and maintaining it will be a challenge. Cross functional support is key in ensuring adherence to QMS, as challenge is awareness about EU/ ISO 13485 certification requirements is low in cross functional teams such as IPD/ RA/ SCM/FPS/ DSD, Marketing. Same can be overcome by promoting awareness about EU MDR/ISO 13485 requirements at the outset/ from time to time. Engage in Notified bodies audits for ISO and CE marking audits and coordinate with all Cipla teams for audit management. Coordinate with Cipla team for audit compliance. Skills & Knowledge: Educational qualifications: MSc./ MPharm/ if MTech then in Biomedical engineering; Certificate courses/diploma in ISO audits highly welcome Relevant experience: At least 9-10 years of experience in Quality of Medical Devices/IVDs /Implants Experience in regulated market product approvals e.g. US FDA is a high plus

Working knowledge of relevant global medical device regulations, requirements, and standards, such as ISO 13485, 21 CFR Parts 803, 806, and 820, ISO 14971, the European Medical Device Directive (93/42/EEC), and EU MDR (2017/745). Provide Quality and Regulatory Affairs input to the product development team and manage all QA & RA responsibilities throughout product development, design changes, and post-market surveillance processes. Establish and analyze key performance indicators to evaluate and continuously improve the Quality Management System (QMS). Possess broad experience and apply professional concepts and company objectives to resolve complex issues in creative and effective ways. Provide regulatory guidance and support to internal teams and stakeholders, including communicating regulatory changes, conducting training on quality and regulatory requirements, and fostering a culture of compliance within the organization. Experience interacting with the FDA and other regulatory authorities. Excellent analytical skills and the ability to synthesize trending data into meaningful information for the organization.

Responsibilities Collaborate with cross functional teams (engineering, manufacturing, regulatory, sourcing, etc.) to lead or support compliance activities to medical device regulations. Review regulatory compliance change notifications and drive associated actions to be compliant by the effective date Lead compliance efforts to various global regulations (E.g. REACH, ROHS, etc.) in alignment with the quality management system Lead or support product regulatory documentation updates (e.g. NRTL reports, tech file, etc.) Support regulatory audits and inspections to ensure post-market surveillance compliance. Qualifications we seek in you! Minimum Qualifications Knowledge of medical regulations including FDA, EU MDR, NMPA/CFDA, and other applicable international regulations Knowledge of regulatory standards such as IEC 60601, ISO13485, 14971 and other applicable standards and substandard. Proficiency in interpreting, applying complex regulations, and preparing associated documentation. Excellent interpersonal communication and collaboration skills Bachelor s degree in engineering, Science or related area Minimum of 2 years of experience working with medical devices regulations and quality management system. proficiency with written English and with neutral English accent Preferred Qualifications/ Skills Strong technical knowledge Effective probing skills and analyzing / understanding skills

Responsibilities Collaborate with cross functional teams (engineering, manufacturing, regulatory, sourcing, etc.) to lead or support compliance activities to medical device regulations. Review regulatory compliance change notifications and drive associated actions to be compliant by the effective date Lead compliance efforts to various global regulations (E.g. REACH, ROHS, etc.) in alignment with the quality management system Lead or support product regulatory documentation updates (e.g. NRTL reports, tech file, etc.) Support regulatory audits and inspections to ensure post-market surveillance compliance. Qualifications we seek in you! Minimum Qualifications Knowledge of medical regulations including FDA, EU MDR, NMPA/CFDA, and other applicable international regulations Knowledge of regulatory standards such as IEC 60601, ISO13485, 14971 and other applicable standards and substandard. Proficiency in interpreting, applying complex regulations, and preparing associated documentation. Excellent interpersonal communication and collaboration skills Bachelor s degree in engineering, Science or related area Minimum of 2 years of experience working with medical devices regulations and quality management system. proficiency with written English and with neutral English accent Preferred Qualifications/ Skills Strong technical knowledge Effective probing skills and analyzing / understanding skills

Why join AliveCor ? At AliveCor, we imagine a healthier world powered by access to personalised intelligent information. Were on a mission to be the world s heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical ECG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, millions of users have taken more than 200 million heart health measurements and counting. Our vibrant team of people are attracted to AliveCor because they want to build something meaningful -- and AliveCor delivers: every day, customers tell us that we ve saved lives. Join us in our mission! The Opportunity: AliveCor seeks a Senior Regulatory Affairs Specialist to join this exciting start-up that is changing the face of mobile health. In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction. You will work closely with Quality, Engineering, Product Management, Marketing and Sales teams to manage product submissions, perform regulatory pre- and post-market analysis, drive product registrations and listings worldwide, and help implement and maintain an ISO 13485 and FDA compliant Quality Management System. If you have what it takes to drive change in the medical marketplace, then this is the opportunity for you. Role & Responsibilities Collaborate and execute regulatory strategies for US, Europe and other global registrations Participate in preparation and review of global regulatory submissions Support government/FDA interactions pertaining to medical device registrations and licensing ; Participate in the development of regional regulatory strategy and update strategy based upon regulatory changes; Assist in the review of advertising and promotional materials; Provide regulatory support to cross-functional product development and project teams throughout the product lifecycle; Support or lead regulatory activities required for US FDA, EU MDR, NMPA, PMDA, ANVISA compliance ; Support worldwide resellers and distributors with product registrations and renewals; Provide regulatory assessment for manufacturing and design changes; Provide regulatory review and approval of change order packets; Support or lead product regulatory intelligence and risk assessments; Assist in maintaining compliance with product post market requirements; Support post-market regulatory actions taken for the products; Support internal and external audits; Ensure compliance with internal procedures and external regulations and standards; Maintain regulatory and quality records and other controlled documents; and Promote a culture of quality throughout AliveCor Requirements Bachelors degree in Science, Engineering, Math, or medical field or equivalent educational experience pertaining to technical writing, scientific method, and problem solving 4+ years of experience in medical device Regulatory Affairs Experience in regulatory affairs for software devices with AI/machine learning algorithms (SaMD) Participated in the preparation of pre-submissions, 510(k)s or de novo submissions Experience with and knowledge of EU Medical Device Regulations Ability to manage small projects: organised, independent, and results-oriented Superb analytical and excellent communication skills, strong team ethic, and attention to detail Preferred candidate profile Advanced degree or Regulatory Affairs Certification from RAPS Process-oriented thinking Supported or lead international submissions (preferably in Asia-Pacific and/or LATAM) Demonstrated competence documenting technical information and communicating it to others Perks and benefits We strive to make your life outside work as smooth as possible while you're at work, and we offer a long list of benefits to make that happen. Hybrid working model Flexible and generous vacation policy Maternity / Paternity Leave/ Adoption/ Commissioning leave Generous Medical Benefits Above market family floater medical insurance coverage including both parents or in law parents Metro connectivity from office A supportive, collaborative group of people who understand that success depends on the team

Key Responsibilities: Requirements gathering and regulatory analysis Support with staffing strategy, screening, and interviews Required Expertise: Hands-on experience with ISO 13485 QMS , CDSCO dossiers , and/or FDA/CE submissions Familiarity with ISO 14971 , IEC 60601 , IEC 62304 , Indian MDR 2017 , EU MDR , and FDA 510(k) processes Strong grasp of technical documents: specs, schematics, test protocols, engineering terminology Excellent documentation, analytical, and communication skills Ability to work independently in a fast-paced, startup-like environment

Prepare and submit regulatory documentation for new and existing products. Monitor and interpret global regulatory requirements relevant to physiotherapy and medical equipment. Maintain regulatory compliance throughout the product lifecycle. Interface with regulatory agencies, notified bodies and external consultants. Ensure accurate and timely product registrations in target markets. Maintain up-to-date Device Master Files (DMF) and Technical Documentation. Support clinical evaluation and risk assessment documentation where required. Ensure products comply with applicable regulations, standards and guidelines Manage change notifications, renewals, amendments and post-market surveillance requirements. Support A for audits, CAPAs, internal documentation practices and inspections from regulatory bodies. Provide regulatory guidance to R&D, QA, Marketing during product development and changes. Review and approve labeling, packaging and promotional materials to ensure compliance. Collaborate with external consultants, legal teams or distributors for country-specific compliance. Monitor regulatory changes and industry updates across markets. Participate in external seminars, forums and internal training to build regulatory awareness. Supporting and enabling effective and efficient communication that results in operational excellence. Skills required: Degree in Biomedical Engineering, Pharmacy or related field. 36 years of regulatory experience in the medical device industry. Strong knowledge of regulatory frameworks (US FDA, EU MDR, CDSCO, ISO 13485). Experience with regulatory submissions and product registrations. Excellent technical data interpretation skills including problem solving Excellent oral and written communication skills with strong presentation skills Demonstrate subject matter and area expertise Excellent computer skills; Good knowledge of document management systems Excellent written and verbal communication skills Highly proficient with Microsoft Word, PowerPoint and Excel. Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines

Regulatory Strategy & Compliance – US FDA, EU MDR, CDSCO Documentation & Regulatory Submissions Regulatory Monitoring & Reporting UDI Submission – GUDID / EUDAMED Regulatory Audits, Inspections, CAPAs & NCs Closure Required Candidate profile BE/BTech in Mechanical, Biomedical, Biotech, or related fields Min 2 years of exp. in RA for medical devices Knowledge of U.S. FDA, EU MDR, CDSCO regulations RAC/GATE certification is a plus

Job Summary We are looking for a detail-oriented and experienced Quality Control Engineer to join our manufacturing team. The ideal candidate will be responsible for implementing and overseeing quality control processes, ensuring all products meet national and international medical device standards, and working closely with production and R&D to resolve quality issues. Key Responsibilities Conduct in-process and final quality inspections for medical devices in accordance with GMP and ISO 13485 standards. Develop and maintain QC protocols, SOPs, and inspection reports. Ensure compliance with regulatory requirements such as CDSCO, MDR 2017, ISO 13485, and CE. Perform root cause analysis and corrective/preventive action (CAPA) for quality issues and non-conformities. Liaise with production, QA, and R&D teams to address quality-related challenges. Monitor and analyze data from incoming raw materials, in-process controls, and finished goods. Maintain proper documentation and assist in internal/external audits. Qualifications & Skills Bachelor's degree in Engineering (preferably in Biomedical, Mechanical, or Industrial Engineering). 25 years of experience in a QC role within the medical device or pharmaceutical industry. Strong knowledge of ISO 13485, QMS, GMP, and applicable regulatory standards. Hands-on experience with measurement tools (e.g., Vernier calipers, micrometers, leak testers). Proficiency in documentation and data analysis. Familiarity with cleanroom protocols and sterilization validation is a plus.

Job Title Design Quality Engineer Job Description Job title: Design Quality Engineer - Medical Devices The Design Quality Engineer DQE provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. The DQE also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes Your role: Ensure appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design. Validate key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability, and costs. Provide effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle. Perform independent technical assessment on product quality performance and post market product quality analysis. Can Lead quality related problem solving and root cause analysis during design and manufacturing. 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. Performs independent technical assessment on product quality performance and post market product quality analysis. Provide leadership and oversight to ensure Quality Management System Compliance. Be able to plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement systems. Ensure the compliance requirements are met during Design review , design verification & Design validation , Design transfer. Apply and facilitate Design for Quality & Reliability best practices (FMEAs, robust design, V&V, root cause analysis & problem solving). You're the right fit if: (4 x bullets max) An Engineering degree in any discipline with at least 8+ years of relevant industry experience. . Core expertise in Design Quality, Systems Engineering, or Reliability Engineering. Medical device industry experience is mandatory . Ability to define detailed systems 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 Usability testing. Ability to lead reliability analysis to assess the risks associated with design concepts. 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, , and ISO 14971. Experience with working in multidisciplinary teams in a high-tech R&D environment. You continuously strive for excellence as a way of life and can inspire others to adopt this mentality of prioritizing quality above all else. You are a self-starter who embraces the change 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 company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers or suppliers 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. . Learn more about . . Discover . . Learn more about . If you're 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 .

Designation: Staff Specialist Labeling & Technical Publications Experience: 7–11 years Location: Gurgaon (GGN) or Bangalore (BLR) Interview Rounds: 8 Work Mode: Hybrid / Onsite Role Overview We are seeking a highly skilled professional to manage and coordinate global labeling and technical publications for medical device products. This role involves regulatory documentation, translation workflows, quality compliance, and cross-functional project leadership within a regulated environment. Key Responsibilities Manage and approve labeling jobs using tools like Microsoft Teams Planner and PLM systems. Coordinate document translations with external vendors and ensure regulatory compliance. Publish approved documents to global portals and maintain accurate versions. Lead and support Engineering Change Requests (ECR/ECN) related to labeling and documentation. Act as the local labeling lead for global projects, tracking progress, managing stakeholders, and reporting risks. Ensure compliance with global quality and regulatory standards (EU MDR, ISO 14971, IEC 62366). Support risk management processes and integrate risk measures into product labeling. Review quality assurance documentation related to product sustenance and lifecycle management. Manage label printing for regulatory submissions and large-scale updates. Must-Have Skills & Qualifications 7–11 years of work experience, with 5+ years in technical writing, labeling, or quality assurance in the medical device domain. Hands-on experience with documentation systems such as onePLM, SharePoint, or similar. Solid understanding of regulatory frameworks including EU MDR, ISO 14971, and IEC 62366. Strong project management capabilities with the ability to manage multiple projects and timelines. Bachelor’s degree in Engineering, Science, or a related technical field. Excellent communication and stakeholder management skills.

• 4-7 years experiences for RA role in medical device and or pharmaceutical industry • Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements.