International Regulatory Strategist

3 days ago

India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000
Regulatory Compliance Professional

We are seeking a detail-oriented, experienced professional to join our global cross-functional team as a Regulatory Compliance Professional. The ideal candidate will have a minimum of 3 years of hands-on experience supporting regulatory submissions and compliance initiatives in the medical device industry.

Key Responsibilities:
  • Own and support regulatory activities for international markets with a focus on U.S. FDA and Health Canada requirements.
  • Contribute to and maintain regulatory documentation including product regulatory files, IFUs, and labeling reviews.
  • Collaborate with R&D, Quality, and Business Unit teams to align regulatory documentation and submission content.
  • Conduct regulatory impact assessments for design changes.
Qualifications:
  • Bachelor of Science in Biomedical Engineering/Life Sciences/Related Field.
  • Minimum of 3 years of regulatory experience in the medical device industry.
  • Proven experience contributing to regulatory filings.
  • Strong understanding of international regulatory body regulations with an emphasis on U.S. FDA and Health Canada.
  • Ability to interpret and apply regulatory requirements to complex technical issues.
  • Excellent communication, organization, and problem-solving skills.
  • Experience in supporting responses to regulatory agencies.
  • Ability to work independently and collaboratively in a cross-functional team environment.
Preferences:
  • Background in Quality Engineering ensuring alignment between regulatory strategy and quality system requirements.
  • Proven experience in contributing to international regulatory submissions.
  • RAC (Regulatory Affairs Certification) or similar professional certification.
  • Internal Auditor Training.

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