Quality Assurance Specialist

1 day ago


Chennai, Tamil Nadu, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 2,01,60,000
Medical Device Quality Assurance Lead

This is an excellent opportunity for a highly skilled and experienced Medical Device Quality Assurance professional to lead our quality assurance initiatives.

The successful candidate will be responsible for ensuring compliance with relevant regulatory requirements, including ISO 13485, MDD, MDR, GMP, GDP, and QMS standards. This will involve coordinating with regulatory authorities, managing risk, and overseeing the development of quality management systems.

  • Key Responsibilities:
  • Ensure compliance with regulatory requirements and standards.
  • Coordinate with local FDA and CDSCO for obtaining required permissions and approvals.
  • Oversee risk management, clinical evaluation, and post-market surveillance (PMS) for Class I, II, and Class III 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

As a key member of our team, you will have the opportunity to make a significant impact on the success of our company. You will work closely with cross-functional teams to develop and implement quality management systems that meet regulatory requirements.



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