Executive QA/RA

3 days ago

Thiruvananthapuram, Kerala, 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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