Senior Medical Devices Quality Assurance Specialist

2 days ago

Kanpur, Uttar Pradesh, India beBeeCompliance Full time ₹ 18,00,000 - ₹ 24,00,000

Our organization seeks a highly skilled Executive QA/RA professional to play a pivotal role in the Medical Device Industry.

This key position involves ensuring seamless compliance with various quality standards, effectively managing regulatory submissions, and overseeing risk management processes.

Key Responsibilities:

  • Ensure adherence to ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
  • Coordinate with local authorities to obtain necessary permissions and approvals.
  • Manage regulatory submissions and guarantee timely approvals.
  • Implement Corrective and Preventive Actions (CAPA) to maintain compliance and foster continuous improvement.
  • Provide support for audits and ensure readiness for regulatory authority reviews.

Candidate Profile:

  • Demonstrate strong understanding of quality systems and regulatory frameworks for medical devices.
  • Possess hands-on experience with regulatory submissions and risk management.
  • Exhibit excellent knowledge of GMP, GDP, and ISO 13485 standards.
  • Display strong communication, documentation, and coordination skills.

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