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Regulatory Affairs Manager - Medical Products

Job offer for Professional in Berlin

WOM is a pioneer and a global leading manufacturer in the field of medical technology. We are looking for reinforcements for our Regulatory Affairs team in Berlin. You should contact us if you like to work independently, would like to break new ground with us in the field of Minimally Invasive Medicine, and are looking for continuous development opportunities.

What we offer

  • Versatile tasks in an exciting work environment
  • International teamwork
  • Appreciation and respect
  • Systematic advanced training by the WOM ACADEMY
  • Space for innovation
  • Career opportunities in an expanding company

Your tasks are

  • Worldwide approval of medical products and their maintenance:
    Support of our customer or in-house preparation of documentation for product approvals and handling of the approval with the relevant authorities and our customers
  • Consulting and coordinating measures with the divisions in all regulatory and safety issues and tasks related to medical devices for new developments and change management
  • Review and approval of development and accompanying documents from the point of view of regulatory affairs
  • Processing of safety-relevant complaints in cooperation with the QM team
  • Implementation / participation in internal and external audits

Your are offering

  • Successfully completed scientific or technical degree program or comparable qualification
  • Some experience in the area of regulatory affairs
  • Knowledge of international approval requirements and underlying laws and standards (medical device directive, inter­national standards)
  • Fluent business English (speaking and writing)

These are your personal strengths

  • You are quality conscious and reliable
  • You are a strong communicator and cooperative
  • Analytical and structured thinking
  • Independent and goal-oriented work is your special strength

If this describes you, we look forward to receiving your detailed application with salary expectations and earliest start date.

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