Our company is a leading provider of innovative medical technology solutions. With our advanced technologies and services, we improve the quality of life of patients worldwide. To strengthen our team at the Burgdorf site in Regulatory Affairs, we are looking for an experienced person as
Regulatory Affairs Manager | 80 - 100%
Ref. No. 7730
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.
Your main tasks
Oversee regulatory activities related to the development, support, and deployment of combination products and medical devices
Develop and implement global regulatory strategies in close collaboration with cross-functional teams
Prepare and manage regulatory submissions for worldwide product approvals
Act as a strategic partner for internal stakeholders across various levels
Support product lifecycle management from a regulatory perspective
Participate in and support audits according to QMS ISO 13485 and 21 CFR 820
Lead or contribute to continuous improvement initiatives within the regulatory function
Your profile
University degree in Engineering, Natural Sciences, Medical Sciences, or equivalent professional experience
Minimum 2 years of professional experience in Regulatory Affairs, ideally with combination products and/or medical devices
Strong organizational and interpersonal skills with a proactive mindset
Fluent in English and good command of German (B1–B2 level)
Ypsomed - making the treatment of chronic diseases possible
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.
