Quality Regulatory Compliance Professional

2 days ago


Amrāvati, Maharashtra, India beBeeRegulatory Full time ₹ 23,59,385 - ₹ 30,19,713

Key Positions: Executive – Quality Assurance and Regulatory Affairs

We are seeking an experienced professional to oversee quality systems and regulatory frameworks for medical devices.

Responsibilities:
  • Ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS standards.
  • Coordinate regulatory submissions, risk management, and post-market surveillance for medical devices.
  • Oversee audits, inspections, and ensure readiness for regulatory authority reviews.
Requirements:
  • Strong understanding of quality systems and regulatory frameworks.
  • Hands-on experience with regulatory submissions, risk management, and PMS.
  • Excellent knowledge of GMP, GDP, and ISO 13485 standards.
Candidate Profile:
  • Strong communication, documentation, and coordination skills.
  • Ability to manage multiple tasks and prioritize deadlines.

The ideal candidate will possess a strong passion for ensuring product safety and quality while maintaining regulatory compliance.

Preferred Skills:
  • Experience with CAPA procedures.
  • Knowledge of clinical evaluation and post-market surveillance.
  • Strong analytical and problem-solving skills.


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