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Executive Quality Assurance Regulatory Affairs Lead

3 weeks ago


Bhavnagar, Gujarat, India beBeeQuality Full time ₹ 15,00,000 - ₹ 20,10,000
Executive Quality Assurance/Regulatory Affairs Lead

This high-profile role oversees quality assurance and regulatory affairs for medical devices, ensuring compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS standards.

  • Responsibilities:
  • Manage risk, clinical evaluation, and post-market surveillance for medical devices.
  • Coordinate submissions and ensure timely approvals.
  • Implement corrective and preventive actions for continuous improvement.
  • Support audits, inspections, and readiness for regulatory reviews.

Required Skills:

  • 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.
  • Effective communication, documentation, and coordination skills.

Benefits:

This critical position offers a unique opportunity to drive quality and regulatory excellence in the medical device industry.

Key Qualifications:

  • Expertise in quality assurance and regulatory affairs for medical devices.
  • Strong leadership and team management skills.
  • Strategic thinking and problem-solving abilities.