Medical Device Quality Assurance Expert

1 day ago

Thrissur, Kerala, India beBeeRegulatoryAffairs Full time ₹ 20,00,000 - ₹ 30,00,000
Executive Quality Assurance / Regulatory Affairs Professional

We are seeking a seasoned Quality Assurance / Regulatory Affairs expert to join our team in the Medical Device Industry.

The ideal candidate will possess in-depth knowledge of quality systems and regulatory frameworks for medical devices, with hands-on experience in regulatory submissions, post-market surveillance, and risk management.

Key Responsibilities:

  • Ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
  • Coordinate with regulatory authorities for obtaining required permissions and approvals.
  • Oversee risk management, clinical evaluation, and post-market surveillance for Class I, II, and 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:

  • Deep 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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