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Medical Device Expert for substance-based medical devices

  • Location: Badenweiler
  • Salary: Negotiable per year
  • Job Type:Contract

Posted 18 days ago

  • Contact: Michael Burgstaller
  • Contact Email: m.burgstaller@sciproglobal.de
  • Start Date: ASAP
  • Expiry Date: 28 April 2021
  • Job Ref: ID3476_1617019554

Position:

  • Development of tailor-made solutions and/or strategies for the approval of substance-based medical devices in accordance with MDR 2017/745 Annex I
  • Development - technical and regulatory - of substance-based medical devices, ideally with knowledge of pharmaceutical and/or cosmetic formulation(s)
  • Preparation of technical documentation for the medical device part of a substance-based medical device according to Annex II/III
  • Evaluation/assessment of customer documentation with a focus on the general safety requirements, Annex I MDR
  • Interactive collaboration with in-house experts on all topics

Skills:

  • Completed education in the field of pharmaceutical or medical technology or comparable educational background
  • Sound knowledge and experience with the regulatory basis defined by the MDR (EU) 2017/745, in particular for the regulation of substance-based medical devices
  • Experience in writing CTD Module 3 and 2.3 in the context of pharmaceutical marketing authorizations or (PIF) Product Information Files for cosmetics
  • Experience in the medical device industry, preferably in positions in Research and Development, Regulatory/Scientific Affairs or Notified Bodies
  • Very good written and spoken German and English skills
  • Proven project management skills
  • High level of teamwork and communication skills

CV to: m.burgstaller@sciproglobal.de