Quality Assurance Specialist

23 hours ago


Kolkata, West Bengal, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Job Title:

Medical Device Quality Assurance Manager

We are seeking an experienced Medical Device Quality Assurance Manager to oversee our regulatory compliance and ensure the quality of our medical devices.

Responsibilities:

  • Develop and implement quality management systems (QMS) to ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
  • Coordinate with regulatory authorities for obtaining required permissions and approvals.
  • Manage risk assessment, clinical evaluation, and post-market surveillance (PMS) for Class I, II, and Class III medical devices.
  • Oversee regulatory submissions and ensure timely approvals.
  • Handle Corrective and Preventive Actions (CAPA) to maintain compliance and continuous improvement.

Requirements:

  • 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.

We offer a competitive salary and benefits package in exchange for your expertise and dedication.



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