International Regulatory Affairs Manager (m/w/d)

The location specified in the vacancy (Aschau, Erfurt or remote) is discussed based on where the candidate lives. Initial training lasts 6 weeks and is held at the main site.

Your tasks
  • International approval of medical devices according to country-specific guidelines and laws
  • Upkeeping existing approvals
  • Communication and contact with internal partners, retailers and external advisers
  • Preparing and drafting marketing authorisation documents for internal product approvals
  • Coordinating activities in close collaboration with internal departments (RA national, Export, etc.).
  • Monitoring and implementing national and international regulatory requirements
Your requirements
  • Completed technical education + further education, alternative; Technical or science degree
  • We welcome candidates who have trained as a Regulatory Affairs Manager
  • Experience in the field of Regulatory Affairs and affinity in working with regulatory requirements
  • Ability to communicate with a range of partners on legally binding matters
  • Good written and spoken English
  • Familiar with MS office package
  • Highly motivated and flexible team player
  • Pragmatic and analytical approach
  • Confident
  • Conscientious and structured approach
We offer

As a reliable employer we support our Königsee team with a host of prospects and flexible offers for all phases in life. Discover us:

  • A structured and detailed initiation at the company sites where a mentor will support you.
  • Varied and responsible tasks including decision pathways and a flat hierarchy
  • A future-proof and permanent job in a growing company
  • A family-oriented and social personnel policy, incorporating flexible working hours, for instance, ensures a healthy work-life balance
  • Sustainability and responsibility for future generations is incorporated into the day-to-day running of the business
  • Open company structure
  • Free parking
  • Water dispensers
  • Monthly vouchers
  • Company pension
  • …. And much more

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Please email your applications with your salary expectations electronically only to Ms Höpping-Schwenk: bewerbung@koenigsee-implantate.de

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