Medical Device Quality Assurance Specialist

2 weeks ago

Palakkad, Kerala, India beBeeRegulatory Full time ₹ 90,00,000 - ₹ 1,20,00,000

Quality Assurance and Regulatory Affairs Expert

We seek an experienced professional to oversee quality assurance and regulatory affairs for a leading medical device company.

Key Responsibilities:
  • Ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements by conducting thorough risk assessments and implementing corrective actions as needed.
  • Coordinate with regulatory authorities, such as the FDA and CDSCO, to obtain required permissions and approvals in a timely manner.
  • Develop and implement effective risk management, clinical evaluation, and post-market surveillance strategies for Class I, II, and III medical devices.
  • Manage regulatory submissions and ensure that all necessary documents are prepared and submitted accurately and on schedule.
  • Identify and address potential issues through Corrective and Preventive Actions (CAPA) to maintain compliance and drive continuous improvement.
  • Support audits, inspections, and ensure that the company is always ready for regulatory authority reviews by maintaining accurate records and documentation.
Candidate Profile:
  • A strong understanding of quality systems and regulatory frameworks for medical devices is essential for this role.
  • Hands-on experience with regulatory submissions, post-market surveillance, and risk management is also crucial.
  • Excellent knowledge of GMP, GDP, and ISO 13485 standards is required.
  • Strong communication, documentation, and coordination skills are necessary to succeed in this position.

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