international regulatory affairs manager.

about the company.
Our client is an emerging medical devices company seeking for a Regulatory Affairs Manager to drive product registeration outside of Hong Kong

• Prepare and compile comprehensive regulatory submissions focused on the European Union Medical Device Regulation and Asia-Pacific markets.
• Manage the lifecycle of regulatory submissions, including addressing ongoing inquiries and requests for additional information from regulatory authorities and Notified Bodies.
• Conduct thorough regulatory and scientific research to support submission requirements and address emerging issues.
• Contribute to the development of regulatory strategies by identifying product classifications and assisting in the formulation of effective pathways to market.
• Support the creation of robust submission documentation through literature reviews and the synthesis of relevant scientific and regulatory information.
• Ensure regulatory compliance by identifying and interpreting applicable standards and guidance documents, and participating in meetings with regulatory agencies under the direction of leadership.