Chief Compliance Officer

6 days ago


Gulbarga, Karnataka, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

We are seeking a seasoned Medical Device Regulatory Affairs professional to take on a key role in ensuring compliance with industry standards.

Key Responsibilities:
  • Ensure adherence to ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements through meticulous planning and execution.
  • Facilitate collaboration with regulatory authorities, including local FDA and CDSCO for obtaining necessary permissions and approvals.
  • Oversee risk management, clinical evaluation, and post-market surveillance (PMS) for Class I, II, and Class III medical devices to maintain high levels of quality and safety.
  • Manage regulatory submissions and ensure timely approvals to avoid delays and disruptions.
  • Develop and implement Corrective and Preventive Actions (CAPA) to address non-conformities and drive continuous improvement.
  • Support audits, inspections, and ensure readiness for regulatory authority reviews by maintaining accurate records and documentation.
Candidate Profile:
  • Profound understanding of quality systems and regulatory frameworks for medical devices is essential for this role.
  • Hands-on experience with regulatory submissions, PMS, and risk management is highly valued.
  • Exceptional knowledge of GMP, GDP, and ISO 13485 standards is necessary for success.
  • Superior communication, documentation, and coordination skills are crucial for effective collaboration with cross-functional teams.


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