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
Arbeitsort
Brunnmattstrasse 6
3401 Burgdorf
