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Senior Quality Assurance and Regulatory Affairs Specialist

2 weeks ago

Kota, Rajasthan, India beBeeRegulatoryAffairs Full time ₹ 1,00,00,000 - ₹ 2,00,00,000

We are seeking a highly skilled professional to join our client in the Medical Device Industry.

Job Description:
  • Quality Assurance and Regulatory Affairs
  • Ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
  • Coordinate with regulatory authorities for obtaining required permissions and approvals.
  • Oversee risk management, clinical evaluation, and post-market surveillance (PMS) for 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.
Required Skills and Qualifications:
  • 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.
Benefits:

This role offers a challenging and rewarding opportunity to make a significant impact on the Medical Device Industry.