Job Title

We, at BioTalent Search , are hiring the right candidate on behalf of our esteemed client in the Medical Device Industry. Position: Executive – Quality Assurance / Regulatory Affairs (2) Location: Daman/ Khopoli Experience: 5- 7 Years Qualification: B.Pharm / M.Pharm (Must have relevant experience in the Medical Device Industry) Key Responsibilities: Ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements. Coordinate with local FDA and CDSCO for obtaining required permissions and approvals. Oversee risk management, clinical evaluation, and post-market surveillance (PMS) for Class Is, II, and Class III medical devices. Manage regulatory submissions and ensure timely approvals. Handle Corrective and Preventive Actions (CAPA) to maintain compliance and continuous improvement. Support audits, inspections, and ensure readiness for regulatory authority reviews. Candidate Profile: Strong understanding of quality systems and regulatory frameworks for medical devices. Hands-on experience with regulatory submissions, PMS, and risk management . Excellent knowledge of GMP, GDP, and ISO 13485 standards . Strong communication, documentation, and coordination skills.