Senior Quality Assurance and Regulatory Affairs Leader

1 week ago


Aurangabad, Maharashtra, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 25,00,000

Quality Assurance and Regulatory Affairs Executive.

Job Description

The position of Quality Assurance and Regulatory Affairs Executive is critical to ensuring compliance with regulatory requirements in the Medical Device Industry. The successful candidate will be responsible for leading a team in implementing quality systems, regulatory frameworks, and industry standards.

Key Responsibilities
  • Ensure compliance with regulatory requirements through effective risk management, clinical evaluation, and post-market surveillance (PMS).
  • Coordinate with regulatory authorities, such as local FDA and CDSCO, to obtain necessary permissions and approvals.
  • Manage regulatory submissions and ensure timely approvals to maintain market access.
  • Identify and implement Corrective and Preventive Actions (CAPA) to maintain compliance and drive continuous improvement.
  • Support audits, inspections, and ensure readiness for regulatory authority reviews.

The ideal candidate will possess excellent communication, documentation, and coordination skills, with hands-on experience in regulatory submissions, PMS, and risk management.

Required Skills and Qualifications

The successful candidate will have:

  • Proven experience in Quality Assurance and Regulatory Affairs.
  • Strong understanding of ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
  • Excellent communication and documentation skills.
  • Ability to coordinate with regulatory authorities and manage regulatory submissions.
  • Hands-on experience in regulatory submissions, PMS, and risk management.

If you are a motivated and experienced professional looking for a challenging role, please apply today



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