9 Eu Mdr Jobs

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.

Regulatory Strategy & Compliance US, FDA, MDR Documentation & Submissions Regulatory Monitoring/ Reporting, Submission of UDI to GUDID/EUDAMED Regulatory Audits and Inspections CAPAs, NCs closure Navigating regulatory requirement for CDSCO, US FDA Required Candidate profile BE/BTech- Mech. min. 3+ years of exp. in regulatory affairs with medical device industry, strong understanding of U.S. FDA and European regulatory requirements, EU MDR 2017, ISO 13485, RAC, CDSCO.

Ensure that all products comply with global, regional, and national regulatory requirements (e.g., FDA 21cfr part 820, EU MDR 2017/745, ISO 13485, MDSAP) Preparation & maintenance of Technical Documentation (Technical Files and Design Dossiers). Required Candidate profile Monitor changes in regulations, standards, and guidelines relevant to the company’s product portfolio, ensuring timely implementation of necessary updates Coordinate with internal teams