Medical Device Regulatory Compliance Expert

3 days ago


Solapur, Maharashtra, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000
Senior Regulatory Affairs Specialist

We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our esteemed client in the Medical Device Industry.

  • The ideal candidate will be responsible for ensuring compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
  • They will coordinate with local FDA and CDSCO for obtaining required permissions and approvals.

Responsibilities include:

  • Overseeing risk management, clinical evaluation, and post-market surveillance (PMS) for Class I, II, and Class III medical devices.
  • Managing regulatory submissions and ensuring timely approvals.
  • Handling Corrective and Preventive Actions (CAPA) to maintain compliance and continuous improvement.

Candidates should possess strong understanding of quality systems and regulatory frameworks for medical devices. They should have hands-on experience with regulatory submissions, PMS, and risk management.

A strong communicator with excellent knowledge of GMP, GDP, and ISO 13485 standards is essential for this role.



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