Senior Regulatory Affairs Manager

8 hours ago

Singapore beBeeCompliance Full time $49,300 - $63,500

Regulatory Affairs Specialist

We are currently seeking a Regulatory Affairs Professional with experience in medical device regulatory affairs to oversee registrations, ensure compliance with regulations, and provide strategic guidance.

Main Responsibilities
  • Develop and submit medical device registration files to regulatory authorities. Monitor submissions in other countries handled by local teams.
  • Offer regulatory strategy advice, product classification, labeling, and compliance requirements guidance.
  • Monitor regulatory updates and provide expertise to ensure ongoing compliance.
  • Support post-market surveillance initiatives.
  • Serve as the primary point of contact for manufacturers' regulatory teams and regulatory bodies, ensuring efficient and timely registration processes.
Requirements
  • A minimum of 2–5 years of experience in regulatory affairs for medical devices.
  • In-depth knowledge of relevant regulations and ability to navigate complex regulatory landscapes.
  • Strong English communication skills; proficiency in Chinese is an asset.
  • Excellent organizational and project management abilities; able to handle multiple submissions simultaneously.
About This Role

This is an exciting opportunity to join our organization as a Regulatory Affairs Specialist.

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