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 field of activity - demanding
  • Implementation of the MDR 2017/745, associated guidelines and standards
  • Creating and maintaining technical documentation for existing products and new developments.
  • Communicating with the responsible approval authorities and notified bodies
  • Carrying out conformity assessment procedures
  • Keeping up with developments in the field of regulatory requirements and implementing measures to meet them
  • Supporting the creation and development of sales-supporting materials (product brochures etc.).
  • Close cooperation with the sales and marketing team as well as regular meetings with related departments
  • Building up product-specific expertise and passing on that knowledge into the company
Your requirements - qualified
  • Completed studies in the field of medical technology ,industrial engineering or product engineering or a comparable qualification.
  • Experience in project management is an advantage
  • Very good understanding of applications and resulting customer requirements
  • Knowledge of the standards governing medical technology
  • Strong customer orientation
  • Pragmatic and analytical approach
  • Confidence and assertiveness
We offer - charming

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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