Medical Device Quality Assurance and Regulatory Specialist

2 days ago


Bikaner, Rajasthan, India beBeeRegulatory Full time ₹ 1,20,00,000 - ₹ 2,50,00,000

We are hiring an experienced professional to represent our esteemed client in the Medical Device Industry.

The position of Executive Quality Assurance and Regulatory Affairs requires 5-7 years of experience and a B.Pharm or M.Pharm degree from a recognized institution, with relevant experience in the Medical Device Industry.

Key Responsibilities:
  • Ensure compliance with quality management systems (QMS), medical device regulations (MDR), and good manufacturing practices (GMP).
  • Coordinate with regulatory authorities for obtaining necessary permissions and approvals.
  • Oversee risk management, clinical evaluation, and post-market surveillance (PMS) 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 drive 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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