Quality Assurance Specialist

2 days ago


Khopoli, Maharashtra, India beBeeQuality Full time ₹ 15,00,000 - ₹ 25,00,000

Senior Quality Assurance and Regulatory Affairs Professional

Job Description

We are seeking a skilled Senior Quality Assurance and Regulatory Affairs Professional to join our esteemed client in the Medical Device Industry.

The ideal candidate will have a strong understanding of quality systems, regulatory frameworks, and industry standards for medical devices.

This is an excellent opportunity for a motivated professional to grow their career while contributing to the success of our client's business.

Key Responsibilities:

  • Ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
  • Coordinate with regulatory authorities such as FDA and CDSCO for obtaining required permissions and approvals.
  • Oversee risk management, clinical evaluation, and post-market surveillance (PMS) for Class I, II, and 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

To succeed in this role, you should possess:

  • A 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

This role offers a competitive salary package and opportunities for professional growth and development.

Other Requirements

Please note that this is a full-time position, and the successful candidate will be expected to work independently and collaboratively as part of a dynamic team.



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