Manager Regulatory Affairs
- Bachelor’s degree in Science, Engineering, or equivalent discipline.
- 5+ years medical device industry experience.
- Track record in Regulatory Affairs with strong medical device submission experience in Europe (CE), USA (510(k), PMA), and ideally ROW.
- Experience leading (virtual and matrix) teams within a regulatory function.
- Experience with quality systems regulations and guidelines, ISO, Medical Device Directive (MDD), 21 CFR Part 11 and other FDA and international regulatory requirements.
- Extensive Knowledge of global adverse event reporting requirements.
If you are interested in this position and would like to know more about it, please contact:
Thema Group Search & Selection
Peter Kremer, Senior Recruitment Consultant / Partner
Tel: +31 6 51 84 61 62