Join a leading provider of innovative medical technology solutions and help improve the quality of life for patients worldwide. At our Burgdorf site, you play a key role in bringing advanced medical technology to market by optimizing processes and ensuring high quality through your structured approach.
Deine Aufgaben
- Oversee regulatory activities for 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 at 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
Was du mitbringst
- University degree in Engineering, Natural Sciences, Medical Sciences, or equivalent professional experience
- At least 5 years of professional experience in Regulatory Affairs, ideally with combination products and/or medical devices
- Experience with FDA processes (such as 510k submission) and application of artificial intelligence is a plus
- Strong organizational and interpersonal skills with a proactive mindset
- Fluent in English (C1) and good command of German (B1–B2 level)
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Über uns
Ypsomed is a successful, rapidly growing family-owned company headquartered in Burgdorf, Switzerland. With over 2,000 employees worldwide, we develop and produce injection and infusion systems for self-medication. Our market-leading products and solutions empower people around the world to manage chronic diseases and enjoy the highest possible quality of life.