In the Business Area Diabetes Care we are looking in Solothurn for an experienced skilled personality as a
Regulatory Affairs Manager
Ref. No.
6142
100%
Your main tasks
- Focus of this position is supporting our rapidly developing in Diabetes Care (active and connected devices)
- Manage the development and implementation of regulatory strategies
- Support and prepare product submission documents with main focus on EU and Canada
- Partner with business stakeholders on different levels
- Support life-cycle management activities
- 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 2 years of professional experience in Regulatory Affairs with focus medical device
- Expertise in Active Medical Devices related regulations and guidance documents in Europe and Canada
- Excellent organizational and people skills
- Very good English knowledge (Level C2 or MT)
- Good German knowledge (Level B1 or B2)
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
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 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.