Regulatory Affairs Manager, Medical Devices, Zuid Holland
For one of my nicest Medical Device clients based in the South of Holland I am recruiting a Regulatory Affairs Project Manager.
This growing international company offers their team members a good work-life balance and a stimulating working environment in which you can develop your career further.
In this role you will be responsible to convert the product portfolio from MDD CE mark to MDR CE mark on a global level.
Your responsibilities will include:
- Lead the RA cross-functional team
- Create and execute MDR strategies
- Obtain CE certificates withing respective timelines
- Create and maintain technical document files with respect to the MDR requirements of DEKRA
- Obtain global approvals for MDR labeled product within the given time line
- Ensure that the new ERP system is setup to manage the transition period to MDR and implement a process across the organisation to manage this transition
We are looking for:
- A senior Regulatory Affairs Professional with global registration experience in a Medical Device company
- With minimal of 3 years of experience in leading strategic cross-functional projects
- Excellent knowledge of the latest MDD and MDR regulations
- Experience in Scrum, Six Sigma, Agile is preferred
- Fluent in English any other language is an advantage
If you are interested contact me directly on my number: +31651968847 or sent me your contact details: email@example.com and I will contact you within 24 hours.