This fast growing medical device manufacturer is looking to hire a Regulatory Affairs Officer to be based in their offices in the Netherlands.
The RA officers are involved in the recording process and to register the product range in international markets.
You will lead, coordinate, implement and monitor registration processes and identify and clarify the organisations that are responsible for the quality standards in the different countries or regions.
In collaboration with colleagues from Research & Development and Sales & Marketing, you will determine which standards comply with international regulations and prioritise which products in which countries or regions will be registered.
You will need good knowledge of international regulations for medical devices , such as CE marking , FDA 510 ( k ) premarket submission , Japan PAL etc. ;
Fluency in Dutch and English and a high degree of independence.
For more information, please contact Kristina Wraight on firstname.lastname@example.org
Job Ref: 9410
Regulatory Affairs Officer | Medical Devices | Netherlands | to €53K