Regulatory Affairs Manager
Would you like to work in a dynamic and fast growing environment? Then apply and join a highly motivated and innovative Regulatory Affairs team at our Burgdorf site as
Ref. No. 7137
Location: Burgdorf | Hybrid
Help us bring to market state-of-the-art medical technology solutions by optimizing processes and ensuring quality through your structured approach.
- Manage regulatory responsibilities associated with the development, support, and deployment of combination products and medical devices within the business area delivery systems
Manage the development and implementation of regulatory strategies
Support and prepare worldwide product submission documents
Partner with business stakeholders on different levels
Support life-cycle management activities
Review quality agreements with customers on regulatory aspects
Cooperation in QMS ISO 13485 and 21 CFR 820 audits
Lead or support continuous improvement initiatives
- University degree preferably in Engineering or Natural/Medical Sciences or equivalent experience
At least 2 years of professional experience in Regulatory Affairs with focus on combination products and/or medical device
Project Management competences preferred
Excellent organizational and people skills
Ability to work in an international cross-functional organization
Very good English knowledge (C2), German is a plus (B1)
More than 2,000 employees worldwide develop and produce injection and infusion systems for self-medication with the Ypsomed Group. We are a successful, rapidly growing, family-owned company headquartered in Burgdorf (CH) with various production sites and subsidiaries around the world. With our market-leading products and solutions, we enable people all over the globe to self-treatment. Despite chronic diseases such as diabetes, obesity, or certain types of cancer, they are provided with the greatest possible quality of life.
Alain Rusconi
Human Resources Expert Recruiting
+41 (0) 34 424 28 64
Burgdorf
Place of work
Brunnmattstrasse 6
3401 Burgdorf
