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Manager Regulatory Affairs

Locatie

Groningen or Munich

Bedrijfsprofiel

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.

Functieomschrijving/taken

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.

Profiel kandidaat

  • 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.

Arbeidsvoorwaarden

The salary is competitive and appropriate for the position.

Contactpersonen

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
E-mail: kremer@themagroup.nl

Tagcloud Manager Regulatory Affairs

Regulatory Affairs - hospital - PMA – Manager - Medical - devices - Groningen - Munich – Medtech – fluorescence - oncology - surgical - FDA - CE - 510k – Breast Cancer - Field - Service
Alphatron Medical Systems BV Innogenetics (now: FUJIREBIO) Galactic Anton Paar Benelux Dr. Reddy's (Octoplus) Tecan Benelux bvba Omron Healthcare NL Forcare Merieux Nutriscience, voorheen Silliker BV (KLANT) Picarro Inc. Alvogen Instrumentation Laboratory NL (Part of WERFEN) MSD Oss PamGene International BV Alko International/Döhler Hamilton Robotics (NL) Qaelum Fluor Hermes Medical Medivators ( Cantel Group) Biomedic BV (now Part Medical) Eurofins Global Central Lab (Medinet) Boma Danone Nederland (Nutricia Zoetermeer Nederland B.V.) KLANT Organ Recovery Systems
Duitsland

Merowingerplatz 1
40225 DUESSELDORF
E-mail

België

BioVille, Agoralaan
Building A bis
B-3590 DIEPENBEEK
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Pivot Park Kloosterstraat 9 
5349 AB OSS
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Nederland

Odiliastraat 92
5401 ZZ UDEN
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