Senior Medical Device Quality Assurance Specialist

3 days ago

Kurnool, Andhra Pradesh, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Medical Device Quality Assurance Lead

We are seeking an accomplished professional to lead quality assurance efforts for medical devices. The ideal candidate will possess a deep understanding of regulatory frameworks and quality systems.

  • Key Responsibilities:
  • Regulatory Compliance: Ensure adherence to ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
  • Regulatory Coordination: Collaborate with local FDA and CDSCO for obtaining necessary permissions and approvals.
  • Risk Management: Oversee risk management, clinical evaluation, and post-market surveillance (PMS) for Class I, II, and III medical devices.
  • Regulatory Submissions: Manage regulatory submissions and ensure timely approvals.
  • CAPA Management: Handle Corrective and Preventive Actions (CAPA) to maintain compliance and continuous improvement.
  • Audit Support: Support audits, inspections, and ensure readiness for regulatory authority reviews.

Candidate Profile:

  • Quality Systems: Strong understanding of quality systems and regulatory frameworks for medical devices.
  • Regulatory Experience: Hands-on experience with regulatory submissions, PMS, and risk management.
  • Standards Knowledge: Excellent knowledge of GMP, GDP, and ISO 13485 standards.
  • Communication Skills: Strong communication, documentation, and coordination skills.

Why This Role?

  • Lead quality assurance efforts for medical devices.
  • Collaborate with regulatory bodies.
  • Ensure compliance with regulatory frameworks.

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