Medical Device Compliance Specialist

5 days ago


Thiruvananthapuram, Kerala, India beBeeQuality Full time ₹ 15,00,000 - ₹ 22,50,000
Executive QA/RA Job Description:

This is a leadership role responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards in the Medical Device Industry.

Key Responsibilities:
  • Ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
  • Coordinate with local authorities to obtain necessary 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 and Qualifications:
  • Strong understanding of quality systems and regulatory frameworks.
  • 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.
Job Requirements:
  • 5-7 years of experience in the Medical Device Industry.
  • B.Pharm/M.Pharm degree required.
  • Relevant experience in Quality Assurance and Regulatory Affairs.


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