Regulatory Affairs and Quality Assurance Executive

2 days ago

Hyderabad, Telangana, India beBeeCompliance Full time ₹ 20,00,000 - ₹ 25,00,000

Regulatory Affairs and Quality Assurance Executive

  • This role focuses on ensuring compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS standards.
  • The ideal candidate will have experience in regulatory submissions, post-market surveillance (PMS), and risk management for Class I, II, and III medical devices.
  • Responsibilities include overseeing audits, inspections, and ensuring readiness for regulatory authority reviews.

Requirements:

  • Proven 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.

Benefits:

  • Strong communication and documentation skills.
  • Ability to coordinate with regulatory authorities.

Other Responsibilities:

  • Manage Corrective and Preventive Actions (CAPA) to maintain compliance.
  • Coordinate with cross-functional teams to ensure timely approvals.

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