Regulatory Affairs Manager (m/w/d)

Ort: Frankfurt am Main, Hessen, Deutschland
Gehalt: a. A.
Spezialisierungen: Life Sciences
Vertragsart: Festanstellung
Jetzt bewerben

Regulatory Affairs Manager (m/w/d)

This position is to be filled full-time (37,5 hours/week).

This tasks are awaiting you:

  • You prepare and submit applications for conformity assessment/clinical trials in the EU and respond to questions from Notified Bodies and Competent Authorities, in a timely and accurate manner
  • You are responsible for the compilation and update of CE-dossiers for registrations/clinical trial applications (CTA), advice to concerned development departments regarding the quality, analytical methods, pre-clinical and clinical development to ensure acceptance of the data in EU and assessment of dossiers of third parties
  • You prepare and update product information texts according to company core data and relevant guidelines
  • You conduct the maintenance/Life-Cycle Management of the CE mark (preparation and submissions of applications for renewals, change notifications, annual updates etc.) in due time
  • You assess proposed changes by the production centers, marketing departments etc. from a regulatory point of view
  • You coordinate regulatory projects and interact with third parties (e.g. consultants, CROs, distribution partner) concerning regulatory issues
  • You develop regulatory strategies, participate in project teams and act as contact person with regards to regulatory requirements
  • You conduct Due Diligences for established products with regards to regulatory aspects

What you need to get started:

  • Natural scientific background (pharmacist, biologist or chemist), approbation, diploma, master degree or PhD
  • Approx. 1-3 years of experience in EU regulatory affairs for medical devices, combined with profound knowledge of the European regulatory landscape
  • Experience with energy based devices is a plus
  • Self-confident manner combined with strong communication skills - also fluent in Business English, further language skills would be preferable
  • Your skills include strategic and analytical thinking, a highly structured way of working and networking abilities

Your contact person for this position is Mrs. Franziska Mayr

You can reach her directly at:

T: +49 (0)89 5519 7774

M: f.mayr(at)progressive.de

Jetzt bewerben