Regulatory Affairs Manager, Medical Devices, Zuid Holland
- Employer
- NonStop Consulting
- Location
- Rotterdam
- Salary
- Negotiable
- Closing date
- Jan 20, 2021
View more
- Sector
- Science, Life Sciences, Anatomy/Physiology
- Contract Type
- Employee
- Hours
- Full Time
- Organization Type
- Corporate
- Jobseeker Type
- Professional
Job Details
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: d.dries@nonstop-recruitment.com and I will contact you within 24 hours.
Company
Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries.
Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery. Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.
The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors.
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