Passion.
Ypsomade, a leading provider of innovative medical technology solutions, is committed to improving patients' quality of life worldwide. To strengthen our team at the Burgdorf site in Regulatory Affairs, we are seeking an experienced individual for the position of
Regulatory Affairs Manager | 80 - 100%
Ref. No. 7730 | Location: Burgdorf | Hybrid
Join us in bringing state-of-the-art medical technology to market by optimizing processes and ensuring quality through a 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 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.
Your profile
* University degree in Engineering, Natural Sciences, Medical Sciences, or equivalent professional experience.
* Minimum of 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 proficient in German (B1–B2 level).
Your benefits
* Flexible working hours: shift work, annual hours, part-time options.
* FlexWork: Work where and when you want within Switzerland.
* Modern work environment with up-to-date facilities.
* Pension fund: Ypsomed covers 55% of contributions.
* Mobility support: Charging stations, Swiss Half Fare Card, parking, proximity to public transport.
* Free sports facilities: Affordable or free gyms across Switzerland.
* Family-friendly policies: Financial support for childcare.
About Ypsomed
With over 2,000 employees worldwide, Ypsomed develops and manufactures injection and infusion systems for self-medication. Headquartered in Burgdorf, Switzerland, we are a family-owned, rapidly growing company dedicated to enabling people with chronic diseases to maintain the best possible quality of life.
Contact
Heiko Sieger
Human Resources Expert
Recruiting
Phone: +41(0)344242634
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