Regulatory Affairs Manager
Our QM & RA department located in Solothurn is currently looking for an experienced and motivated
Support and prepare product submission documents with main focus on EU
Prepare regulatory strategies and submission documentations
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.)
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Your main tasks
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 preferred
Previous experience with MDR, IVDR experience is a plus
Strong organizational skills and high efficiency
Ability to communicate adequately with different stakeholders and on different levels
Very Good German knowledge (Level C2 or MT)
Good English knowledge (min. Level B1)
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.
Further information