Regulatory Expert

2 days ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 8,00,000 - ₹ 15,00,000

Our organization is seeking a seasoned regulatory expert to spearhead international regulatory initiatives. With a minimum of 3 years of experience in the medical device industry, this individual will leverage their expertise to drive compliance and submission strategies.

The ideal candidate will have a deep understanding of U.S. FDA and Health Canada regulations, with a strong emphasis on communication, collaboration, and problem-solving skills. They will be responsible for navigating complex regulatory frameworks, conducting impact assessments, and ensuring alignment between global teams.

About the Role:
  • Develop and implement effective regulatory strategies
  • Contribute to and maintain comprehensive product documentation
  • Collaborate with cross-functional teams to ensure regulatory compliance
  • Conduct regular impact assessments to inform design changes
Requirements:
  • Bachelor of Science in Biomedical Engineering, Life Sciences, or related field
  • Minimum 3 years of regulatory experience in the medical device industry
  • Proven track record of contributing to successful regulatory submissions
  • Strong knowledge of international regulatory frameworks, with emphasis on U.S. FDA and Health Canada requirements
  • Excellent analytical, communication, and problem-solving skills
Bonus Requirements:
  • Background in Quality Engineering to ensure regulatory strategy aligns with quality system requirements
  • Experience in supporting responses to regulatory agencies
  • RAC (Regulatory Affairs Certification) or similar professional certification

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