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4 weeks ago
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.
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