Regulatory Affairs Manager (m/f/d) / Medical Technology(m, f, d)

  • Fulltime
  • Hamburg
  • immediately
Apply now

Job Description

We have been selling medical and laboratory consumables for over 75 years. Worldwide wholesale and export, as well as our own production facilities, make our business exciting and diverse. We are a family business – traditional with courage and trend for constant development and flexibility in the market – with headquarters in Hamburg.

We have a responsible position with varied and exciting areas of responsibility to offer.

Do you have an independent, structured and solution-oriented way of working? Then become part of our team and apply for the position of Regulatory Affairs Manager.

Your tasks

  • Creation and maintenance of technical documentation in teamwork
  • Coordination of laboratory tests
  • Preparation, execution and evaluation of tests and validations
  • Registration of medical devices
  • Processing of regulatory customer inquiries
  • Processing and evaluation of new product designs/modifications
  • Coordination and collaboration in regulatory projects (change management)
  • Carrying out GAP analyses for new norms/standards/guidelines
  • Creation and review of process descriptions, work instructions and forms

Your profile

  • Successfully completed studies in the field of medical technology, regulatory affairs or an equivalent profile
  • Knowledge of the relevant standards (MDR, ISO 14971, EN ISO 13485, etc.)
  • Production experience is desirable
  • IVD experience and sterilization experience desirable, but not a must
  • Good written and spoken German and English skills
  • Experience in the development of medical devices
  • Good knowledge of MS Office products
  • At least three years of professional experience
  • Loyalty, ability to work in a team, results-oriented and independent way of working

Are you interested?

What awaits you with us

  • Flexitime
  • 39 hrs./week
  • Flat hierarchies, short decision-making processes, lots of freedom at work
  • A professional and highly motivated team as well as an inspiring environment to deliver top performance together
  • Maximum creative freedom for further development
  • additional bonus payments
  • Job bike
  • The usual: Coffee & tea and on Friday there is a “family breakfast” for everyone
Apply now!

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    Ansprechpartner

    Laura Cyll

    Customer consultant