Medical Device Regulatory Affairs Specialist

3 days ago

Singapore beBeeRegulatory Full time $80,000 - $120,000

Job Overview

We are seeking a highly skilled regulatory professional to join our team.

  • Key Responsibilities:
  • Registration Management: Prepare, review, and submit medical device registration dossiers to relevant authorities. Monitor submissions in other ASEAN countries handled by local personnel.
  • Regulatory Strategy:
  • Advise on product classification, labelling, and compliance requirements.
  • Compliance Monitoring:
  • Monitor regulatory changes and provide guidance to ensure ongoing compliance in Singapore and ASEAN markets.
  • Post-Market Surveillance:
  • Support activities related to monitoring the performance of registered medical devices.
  • Customer Interface:
  • Serve as a point of contact for manufacturers' regulatory teams and regulatory authorities, ensuring smooth and timely registration processes.

Requirements:

  • A minimum of 2-5 years of experience in regulatory affairs, preferably from prior work in HSA or a regulatory role in medical devices.
  • Strong knowledge of Singapore's medical device regulations (HSA); familiarity with other ASEAN regulations is advantageous.
  • The ability to communicate effectively in English and Chinese is required.
  • Excellent organizational and project management skills; able to handle multiple submissions simultaneously.
  • Familiarity with the Therapeutic Products License (TPL) is desirable.

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