Regulatory Compliance Expert

2 days ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 18,00,000 - ₹ 25,00,000

Seeking a seasoned professional for a key regulatory role.

We are seeking an experienced International Regulatory Specialist with a minimum of 3 years of hands-on experience supporting regulatory submissions and compliance initiatives. The ideal candidate will have a proven ability to navigate complex regulatory frameworks with a focus on U.S. FDA and Health Canada requirements.

Responsibilities Include:

  • Lead regulatory activities for international markets.
  • Contribute to and maintain comprehensive regulatory documentation including product regulatory files, IFUs, and labeling reviews.
  • Collaborate with cross-functional teams to align regulatory documentation and submission content.
  • Conduct thorough regulatory impact assessments for design changes.

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