Leading Medical Device Quality Assurance and Regulatory Expert

3 days ago

Rajkot, Gujarat, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Senior Quality Assurance and Regulatory Affairs Specialist

This role is responsible for ensuring adherence to quality systems and regulatory frameworks within the medical device industry. The ideal candidate will have a strong understanding of GMP, GDP, ISO 13485 standards, and regulatory submissions.

  • Key Responsibilities:
    • Ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
    • Collaborate with regulatory bodies for obtaining required permissions and approvals.
    • Oversee risk management, clinical evaluation, and post-market surveillance for Class I, II, and III medical devices.
    • Manage regulatory submissions, ensuring accuracy and completeness of documentation.
    • Handle Corrective and Preventive Actions (CAPA) to maintain compliance and continuous improvement.
    • Assist with audits, inspections, and ensure readiness for regulatory authority reviews.
  • Requirements:
    • Strong quality expertise in medical devices.
    • Excellent knowledge of GMP, GDP, and ISO 13485 standards.
    • Strong communication, documentation, and coordination skills.

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