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
