3.0 - 8.0 years

2 - 5 Lacs

Faridabad

Work from Office

We are looking for a skilled and detail-oriented QA Executive to join our team. The candidate will be responsible for ensuring the quality and regulatory compliance of medical devices in line with EU MDR 2017/745 and Indian Medical Device Rules (IMDR). This role involves preparing, reviewing, and updating key technical and regulatory documentation and supporting post-market surveillance activities. Roles & Responsibilities Preparation, review, and updating of Technical Files as per EU MDR 2017/745 and Device Master Files (DMF) as per IMDR . Maintenance of General Safety and Performance Requirements (GSPR) documentation in compliance with applicable guidelines. Preparation of Risk Management Plans and Reports as per ISO 14971 and other applicable standards. Development and review of Clinical Evaluation Protocols and Reports (CEP/CER) as per MDR/IMDR guidelines. Preparation and maintenance of Post-Market Surveillance (PMS) , Post-Market Clinical Follow-up (PMCF) , and Periodic Safety Update Reports (PSUR) . Documentation of Design and Development activities, ensuring alignment with regulatory and internal design control requirements. Drafting and reviewing Usability Engineering Protocols and Reports in compliance with ISO 62366. Monitoring, tracking, trending, and reporting of all reportable events , including serious/adverse incidents and field safety corrective actions (FSCA) . Keeping up to date with current national and international regulations, standards, and best practices relevant to the medical device industry. Ensure proper handover of responsibilities to designated personnel during absence. Desired Candidate Profile Prior experience in quality assurance or regulatory affairs for medical devices. In-depth understanding of EU MDR 2017/745 , IMDR , and related standards (e.g., ISO 13485, ISO 14971, ISO 62366). Strong documentation and review skills. Attention to detail with good organizational and analytical abilities. Effective communication skills and the ability to work independently as well as in a cross-functional team.

Posted 13 hours ago

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