Regulatory Affairs specialist, Netherlands wide
- Employer
- NonStop Consulting
- Location
- Flemish Brabant
- Salary
- Negotiable
- Closing date
- Jan 1, 2021
View more
- Sector
- Science, Physical Sciences and Engineering, Biomedical Engineering
- Contract Type
- Employee
- Hours
- Full Time
- Organization Type
- Corporate
- Jobseeker Type
- Professional
Job Details
You will ensure that the products meet the legal requirements in the region for in vitro diagnostics and research and development of medical devices. You will receive support when submitting registration documents to relevant Regulatory authorities. You do this in collaboration with the QA, Product development and technical support departments.
Your responsibilities:
- You support in preparing regulatory reports for new products
- You keep track of all changes of registrations and update information when necessary
- You write and maintain technical documentation for Regulatory submissions
- Review and approval of artwork, labeling and promotional material
- You ensure the quality of RA related documentation
- You are well informed of new developments in the field of national and international regulations in the field of IVDs and you implement any changes
Your profile:
- You have a master in a life science discipline
- Minimum 3 years of experience in a Regulatory Affairs role in Medical devices
- Well-informed about relevant international regulations in the field of IVDs and possible changes
- ISO 13485, 21 CFR 820 knowledge
- You speak and write English fluently and you also speak Dutch
Are you or do you know someone looking for a new challenge within Regulatory Affairs then apply now or contact me directly via the contact details below
Debie Biharie
Recruitment Consultant - Life Sciences Regulatory Affairs - Netherlands
BE: +32 289 198 99 | NL: +31 207 091 070 | LU: +35 220 204 215
Internal Extension: 3394
Email: D.Biharie@nonstop-recruitment.com
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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