Regulatory Affairs Manager National Focus: Purity, biology & sterilisation (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 and associated guidelines and standards (including EN ISO 13485, EN ISO 10993, ISO 19227, EN ISO 11137, EN ISO 14644 etc.)
  • Carrying out cleanroom cleaning validations and qualification measures
  • Planning and supervising sterilisation validations (gamma sterilisation)
  • Planning and implementing or supervising routine biocontamination and product purity tests
  • Training our employees and making them aware of product hygiene
  • 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
  • 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 biology, biotechnology, chemistry or a comparable qualification
  • Experience in sterilisation, biocompatibility or product purity
  • Experience in cleanrooms
  • Knowledge of the standards governing medical technology
  • Pragmatic and analytical approach
  • Confidence and assertiveness
  • Highly motivated and flexible team player
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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