Medical Device Compliance Specialist

3 days ago


Thoothukudi, Tamil Nadu, India beBeeCompliance Full time ₹ 50,00,000 - ₹ 1,00,00,000
Medical Device Compliance Specialist

We are seeking a highly skilled Medical Device Compliance Specialist to join our team. The ideal candidate should have experience in Quality Assurance and Regulatory Affairs, with a strong understanding of quality systems and regulatory frameworks for medical devices.

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.

Requirements:

  • 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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