Title: Regulatory Affairs Manager
Burgdorf, CH
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%
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 5 years of professional experience in Regulatory Affairs, ideally with combination products and/or medical devices
- Previous experience with FDA (e.g. 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)
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.
Ypsomed AG
Alain Rusconi // Human Resources //
Telefon +41344242864 //
www.ypsomed.ch //