Executive QA/RA

3 days ago

Khopoli, Maharashtra, India BioTalent Search® Full time
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.

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