Senior Quality Manager

2 weeks ago

Ellore, Andhra Pradesh, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,00,000
Quality Assurance and Regulatory Affairs Leader

We are seeking an experienced professional to lead Quality Assurance and Regulatory Affairs for a leading Medical Device client.

As a seasoned expert in quality systems and regulatory frameworks, you will be responsible for ensuring compliance with regulatory requirements, managing risk, and overseeing the development of quality management systems.

Key Responsibilities:
  • Ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS standards.
  • Coordinate with local authorities for obtaining required permissions and approvals.
  • Manage 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.
  • Hands-on experience with regulatory submissions and risk management.
  • Excellent knowledge of GMP, GDP, and ISO 13485 standards.
  • Strong communication, documentation, and coordination skills.
Experience:

A minimum of 5-7 years of experience in Quality Assurance and Regulatory Affairs in the Medical Device Industry is preferred.

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