At our site in Burgdorf in the field of Regulatory Affairs, we are looking for a personality as a
Ref. No.
4405
100%
Your main tasks
- Accountable for the definition of regulatory strategies and the preparation of submission documents of reusable pen injector medical devices to worldwide regulatory authorities with a particular focus on EU and USA
- Act as Regulatory Affairs expert within development projects
- Manage Lifecycle Management activities
- Correspondence with customers and authorities
- Ensure regulatory and organizational compliance with all applicable regulations, standards and internal policies
- Support of QMS ISO 13485 and 21 CFR 820 audits
- Contribute to departmental projects and tasks
Your profile
- Higher education or equivalent experience
- Proven track record of professional experience in Regulatory Affairs with focus medical device
- Ideally experience in software as a medical device and digital health preferred
- You enjoy working in an international, diverse and cross-functional organization
- You are a team-player with excellent organizational and communication skills, demonstrating a learning mind-set
- Your profile is completed by good German (B1) and English (B2) knowledge
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.
We are looking forward to receiving your online application with details of availability (period of notice) and salary expectations.
Contact
Irene Molnar
Human Resources Manager
+41 (0) 34 424 33 19
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 35 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 1900 employees.