Registration Compliance Expert

4 days ago

Singapore beBeeRegulatory Full time $49,100 - $63,500
Medical Device Registration Specialist

We are seeking a highly skilled Medical Device Registration Specialist to manage medical device registrations, ensure compliance with regulations, and provide guidance on regulatory strategy.

Key Responsibilities:
  • Prepare, review, and submit medical device registration dossiers to regulatory authorities. Monitor submissions in other regions handled by local regulatory personnel.
  • Advise on regulatory strategy, product classification, labeling, and compliance requirements.
  • Monitor regulatory changes and provide guidance to ensure ongoing compliance in various markets.
  • Support post-market surveillance activities.
  • Act as a point of contact for manufacturers' regulatory team and regulatory authorities, ensuring smooth and timely registration processes.
Requirements:
  • Minimum 2–5 years of regulatory affairs experience, either from prior work in the health sciences authority or a regulatory affairs role in medical devices.
  • Strong knowledge of Singapore medical device regulations; familiarity with other regional regulations is an advantage.
  • Ability in speaking both English and Chinese is a requirement. We have clients all over the world.
  • Strong organizational and project management skills; able to handle multiple submissions simultaneously.
  • Familiarity with therapeutic products license is preferred.

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