At our site in Solothurn in the field of Regulatory Affairs, we are looking for a personality as a
Ref. No.
3683
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Your main tasks
- Support and prepare product registrations with main focus on USA and EU
- Support of development projects with a focus on regulatory aspects
- Evaluation of change requests
- Contract negotiations with customers on regulatory aspects
- Support of customers in regulatory issues and preparation of regulatory documents for medical devices and combination products
- Communication and correspondence with authorities
- Cooperation in quality audits
- General QM tasks (Creation of Q-documents, trainings etc.)
Your profile
- PhD degree preferably in Natural Sciences or Medical Sciences
- At least 5 years of professional experience as Regulatory Affairs Manager with focus medical device
- Knowledge of the registration of medical device software
- Strong organizational skills and high efficiency
- Ability to communicate adequately with different stakeholders and on different levels
- Good German knowledge (Level B1 or B2)
- Very good English knowledge (Level C2 or MT)
Your perspective
With us you will find interesting job content, promising development opportunities and attractive employment conditions. We offer you the prospect of helping to shape the innovation-driven and quality-oriented world of medical technology.
Contact
Jan von Felten
HR Recruiting Partner
+41 (0) 34 424 46 77
Your future place of work
Solothurn
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 1800 employees.