Medical Device Regulatory Affairs Professional

1 day ago

Dombivli, Maharashtra, India beBeeCompliance Full time ₹ 1,00,00,000 - ₹ 2,00,00,000

Regulatory Compliance Specialist

We are seeking an experienced Regulatory Compliance Specialist to join our esteemed organization in the Medical Device Industry.

Key Responsibilities:

  • Ensure compliance with regulatory requirements such as ISO 13485, MDD, MDR, GMP, GDP, and QMS.
  • Coordinate with local 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.
  • 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.

Why This Role Matters:

This role plays a critical part in ensuring our medical devices meet regulatory standards, protecting patient safety, and maintaining our reputation in the industry.

What We Offer:

  • A dynamic work environment with opportunities for growth and development.
  • A competitive compensation package and comprehensive benefits.
  • The chance to work with a talented team dedicated to excellence in medical device regulation.

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