Senior Regulatory Affairs Executive (Medical Devices, IS0 13485) / East Area

Our client is a global Medical device manufacturers providing healthcare regulatory consultancy across Asia. Due to their current expansion plan, they are looking for a Senior Regulatory Affairs Executive to join their team, in hopes of developing the current high performing team. They are located in the East area.

• Determine whether products are classified as medical devices and identify appropriate regulatory pathways and risk classifications
• Prepare and submit regulatory applications including product registrations, renewals, and change notifications to relevant authorities
• Follow up on submissions and address authority feedback to support successful approvals
• Liaise with internal teams and external stakeholders to resolve regulatory queries and support product registration activities
• Maintain and update regulatory databases and ensure documentation accuracy and compliance
• Develop ...