Abbott
Associate, RA
Job Description
Abbott Diagnostics Medical Co., Ltd. supply variety of rapid diagnostics products globally.
The Regulatory Affairs Specialist provides a support role to the physical and legal manufacturing site at Chiba, Japan.
This position provides regulatory expertise in the IVD / Medical Device area to execute regulatory activities with cross functional on site or global teams including but not limited to: IVDR teams, EU Regulatory, International Regulatory, Marketing / PLC, Supply Planning, Customer Service, etc. to ensure all internal and external requirements are met prior to and after product release.
+ Implement regulatory activities to ensure
+ regulatory requirements compliance and earliest possible introduction of product(s)
+ regulatory impacts for post market change management activities
+ Global registration of change associated with the key project
+ Update of technical file and labelling associated with the key project
+ Interface ...
The Regulatory Affairs Specialist provides a support role to the physical and legal manufacturing site at Chiba, Japan.
This position provides regulatory expertise in the IVD / Medical Device area to execute regulatory activities with cross functional on site or global teams including but not limited to: IVDR teams, EU Regulatory, International Regulatory, Marketing / PLC, Supply Planning, Customer Service, etc. to ensure all internal and external requirements are met prior to and after product release.
+ Implement regulatory activities to ensure
+ regulatory requirements compliance and earliest possible introduction of product(s)
+ regulatory impacts for post market change management activities
+ Global registration of change associated with the key project
+ Update of technical file and labelling associated with the key project
+ Interface ...