Job Detail

Stellenbeschreibung

Your key responsibilities

• You are responsible to make our high-end products compliant to the new Medical Device Regulation (MDR) while creating, updating and remediating the Technical Documents with quality and clinical content.


• You review, assess and update design requirements, Requirement Management documents, Risk Files, etc.


• You will closely collaborate with the biomechanical department, the Quality department as well as the technical publication team to drive the new registrations.


• Within the scope of the R&D MDR project you will be part of the project team and work closely with related departments working on the same project.

What are we looking for?

• You hold a Bachelor/Master degree in Engineering, Quality or Biomedical and you have gained at least 2 years of professional experience working in a highly regulated industry (e.g. medical, pharmaceutical, automotive).


• Ideally you gained working experience in the medical device industry and knowledge of the applicable regulations (FDA, MDD, New MDR).


• Apart from your familiarity with design controls within a regulated industry you easily write technical documents in a clear manner.


• You are characterized by analytical reasoning, a focused, pro-active and solution oriented work style along with a high sense of process thinking and team driving skills.


• You value an international working environment where you can use your excellent command of both English and German. Good knowledge of French is an advantage.

We are looking forward to your online application via our career page, reference number R411192.

Please notice that the title of this advertisement can differ from the position title.

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