Senior Regulatory Affairs Professional

3 days ago


Belgaum, Karnataka, India beBeeCompliance Full time ₹ 20,00,000 - ₹ 25,00,000
Medical Device Compliance Specialist

We are seeking an experienced Medical Device Compliance Specialist to join our esteemed client in the medical device industry.

  • Key Responsibilities:
    • Ensure adherence to ISO 13485, MDD, MDR, GMP, GDP, and QMS standards.
    • Coordinate with regulatory authorities for obtaining required permissions and approvals.
    • Oversee risk management, clinical evaluation, and post-market surveillance (PMS) for 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.
  • Required Skills:
    • 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.
  • Benefits:
    • Opportunity to work with a leading medical device company.
    • Collaborative team environment.
    • Professional development and growth opportunities.
  • How to Apply:
    • Send your resume and cover letter to [insert contact information].


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