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Regulatory Affairs Manager

Ypsomed AG
Solothurn

1M

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Regulatory Affairs Manager

Our RA department located in Solothurn is currently looking for an experienced and motivated

Ref. No.

2370

Your main tasks
  • Support and prepare product submission documents with main focus on USA and EU
  • Prepare regulatory strategies
  • Support of development projects with a focus on regulatory aspects
  • Evaluation of change requests
  • Review quality agreements with customers on regulatory aspects
  • Communication and correspondence with authorities
  • Cooperation in QMS ISO 13485 and 21 CFR 820 audits
  • General QM tasks (Creation of Q-documents, trainings etc.)
Your profile
  • University degree preferably in Engineering or Natural / Medical Sciences or equivalent experience
  • At least 5 years of professional experience in Regulatory Affairs with focus medical device
  • Experience with active medical devices and / or software preferred
  • Previous experience with US preferred and previous experience with MDR a plus
  • Strong organizational skills and high efficiency
  • Ability to communicate effectively with different stakeholders and on different levels
  • Good German knowledge (Level B1 or B2)
  • Very good English knowledge (Level C2 or MT)
Your perspective
Contact

Irene Molnar
Human Resources Manager

+41 (0) 34 424 33 19

Your future place of work
The Ypsomed Group

The Ypsomed Group is a leading developer and manufacturer of injection and infusion systems for self-medication and a renowned diabetes specialist with over 30 years' experience. Ypsomed has its headquarters in Burgdorf, Switzerland, and operates a global network of manufacturing sites, subsidiaries and distributors. The Ypsomed Group employs around 1700 employees.

Ypsomed AG
Weissensteinstrasse 26
4500 Solothurn