Quality and Compliance Leader

7 days ago

Gurgaon, Haryana, India beBeeRegulatory Full time US$ 2,00,000 - US$ 3,00,000
Lead Quality Assurance and Regulatory Affairs Specialist

You will be responsible for leading the development and implementation of regulatory strategies to ensure compliance with global and regional requirements.

  • Develop and implement quality-related activities and systems in compliance with Indian and international medical device regulations.
  • Navigate a complex matrix environment, collaborating with cross-functional teams to manage licensing, submissions, renewals, inspections, post-market surveillance, and regulatory intelligence.

Key qualifications include:

  • A minimum of 10-12 years of experience in Quality Assurance and Regulatory Affairs, preferably in the healthcare industry and ideally within the MedTech sector.
  • A strong understanding of the Indian Medical Device Rules (IMDR) under Drugs & Cosmetics Act 1940 and global regulatory frameworks.
  • Proven leadership in managing audits and regulatory submissions.
  • Strong collaboration and communication skills to influence effectively in a matrixed environment.
  • Proven strategic thinking balancing immediate compliance with long-term capability building.

This role is ideal for those seeking a challenging opportunity to drive quality and compliance initiatives forward. The successful candidate will be recognized as a subject matter expert in their field.

The ideal candidate will have a proven track record of success in similar roles and a passion for staying up-to-date with the latest industry trends and developments. As a member of our team, you will enjoy a competitive salary and flexible benefits package.

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