Quality Assurance and Regulatory Affairs Expert

6 days ago


Khopoli, Maharashtra, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

We are seeking a seasoned Quality Assurance and Regulatory Affairs Expert to drive our Medical Device Industry operations forward.

Key Responsibilities:
  • Ensure seamless compliance with regulatory standards including ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
  • Collaborate closely with local regulatory authorities for timely approvals and permissions.
  • Oversee risk management, clinical evaluation, and post-market surveillance (PMS) initiatives for Class I, II, and III medical devices.
  • Manage regulatory submissions efficiently and ensure timely approvals.
  • Develop and implement Corrective and Preventive Actions (CAPA) strategies to maintain compliance and foster continuous improvement.
  • Provide support for audits, inspections, and ensure readiness for regulatory authority reviews.

The ideal candidate will possess in-depth knowledge of quality systems and regulatory frameworks for medical devices, hands-on experience with regulatory submissions, PMS, and risk management, as well as exceptional understanding of GMP, GDP, and ISO 13485 standards.



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