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Regulatory Affairs Manager (m/f) for IVD Products

Location: Frankfurt am Main, Hessen Salary: Verhandelbar
Sector: Life Sciences Type: Permanent

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Regulatory Affairs Manager (m/f) - IVD

Location: near Frankfurt
Start: immediately
Contract type: permanent job

You want to be part of a global team of innovators, leaders and creators?

Then start your career at a medical device company, which specialises in the development of state-of-the-art instruments and reagents for life science research laboratories and health-care facilities all over the world.

Your job:

  • Managing a team of Regulatory Affairs Specialists
  • Supervising the preparation of documents for Worldwide registration
  • Assessing compliance with the relevant regulation for in vitro diagnostic medical devices
  • Communication and reporting to supervisory authorities (BPDR), and notified bodies
  • Managing all submission and registration processes for in vitro diagnostic medical devices at national and international level (CE marking and US FDA)
  • Developing, coordinating and implementing strategy to get market authorisation according to project planning

The requirements:

  • Knowledge of the Medical Devices regulatory framework (CE marking, CFR part 820)
  • Successful degree in technical studies or any other science studies
  • Several years of experience in the Medical Device field (IVD) and experience in licensing projects (FDA BLA's, 510k's)
  • Fluent in English
  • Organisational capacity
  • GMP knowledge

This challenge sounds interesting?

I am looking forward to your application. Please send me your application and CV (in English language; incl. earliest start date and salary expectations) to r.nestmann[at]progressive.de or call me for more information under 089 5519 7750.

Sthree Germany is acting as an Employment Agency in relation to this vacancy.