Manager Regulatory Affairs
Our customer is a high-tech start-up focused on developing a real-time Fluorescence Image Guided Surgery platform combining targeted imaging agent and a device for efficient tumors visualization during oncology surgical procedures.
Lead our customers worldwide regulatory submissions for the Explorer Medical Device product lines. Align with Program Management functions to support new product development, product launch, product life cycle management and corporate objectives.
- 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.
The salary is competitive and appropriate for the position.
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
Tagcloud Manager Regulatory Affairs
Regulatory Affairs - hospital - PMA – Manager - Medical - devices - Groningen - Munich – Medtech – fluorescence - oncology - surgical - FDA - CE - 510k – Breast Cancer - Field - Service