Regulatory Affairs Specialist

22 hours ago


Singapore Recruit Express Full time

At Recruit Express, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong background in medical device regulatory compliance and be able to ensure that our products meet safety and performance requirements of regulatory agencies.

Key Responsibilities:
  • Prepare and complete product registration tasks, including new product registration, registration amendment, and renewal registration.
  • Collaborate with lab technicians to ensure product tests/samples meet safety and performance requirements.
  • Prepare clinical trial and evaluation report applications according to government regulations, hospital ethics committee needs, and company requirements for submission.
  • Create local language labels and Instruction For Use in compliance with country regulations before passing them to Supply Chain.
  • Liaise with regulatory agencies to facilitate and expedite review and approval of company products, registrations, submissions, reformulations, etc.
  • Maintain proper records in the Module Change Request and JDE system to comply with local and company regulatory and quality requirements.
Requirements:
  • Degree in Biomedical/Material Science or relevant discipline.
  • Minimum 3 years of experience in RA work, particularly in medical devices.


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