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Online Laboratory Magazine
03/09/2021

(Senior) Regulatory Affairs Manager (m/f/d)


  • 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
  • You prepare and submit applications for conformity assessment / clinical trials of non-active implantable medical devices 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's core labelling according to available 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


» Job description


Employer:
Merz Pharma GmbH & Co. KGaA
Location:
60318 Frankfurt am Main