36 Eu Mdr Jobs - Page 2

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. Prov...

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 ...

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 ...

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 ...

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 req...

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 co...

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, supportabili...

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. Publis...

• 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.