Chief Medical Device Compliance Officer

1 week ago


Alleppey, Kerala, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Executive Quality Assurance Specialist">

We are seeking a seasoned quality assurance professional to lead our medical device regulatory affairs strategy.

Position Overview:

Key Responsibilities
  • Ensure compliance with ISO 13485, MDD, and MDR requirements.
  • Coordinate with regulatory authorities for obtaining required 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 continuous improvement.

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 standards.
  • Strong communication, documentation, and coordination skills.
Benefits:
  • Opportunity to work in a dynamic industry with the potential for growth and advancement.
  • Collaborative work environment with experienced professionals.

Please submit your application if you have the necessary qualifications and experience.



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