RA Specialist, Medical Device

This role is responsible for managing pharmaceutical applications for our products and overseeing related pharmaceutical affairs tasks.

Key responsibilities include:

• Handling pharmaceutical application procedures for dental products, such as equipment, dental materials, and implants.
  


• Ensuring compliance with the Pharmaceuticals and Medical Devices Act as part of the pharmaceutical affairs department.
  


• Obtaining manufacturing and sales approval for medical devices (Class I to III), securing certifications, and managing change notifications.
  


• Overseeing business operations in accordance with the Pharmaceuticals and Medical Devices Act, including manufacturing site registration.
  


• Preparing and submitting insurance coverage application documents.
  

Requirements

• Experience in regulatory application work in the medical industry
  


• Experience in regulatory application work for implant products
  


• English: Business level reading and writing​
  

Benefits

• Flex time applicable