Regulatory Affairs Manager

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. 7948
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
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Oversee regulatory activities related to the development, support, and deployment of combination products and medical devices
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Develop and implement global regulatory strategies in close collaboration with cross-functional teams
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Prepare and manage regulatory submissions for worldwide product approvals
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Act as a strategic partner for internal stakeholders across various levels
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Support product lifecycle management from a regulatory perspective
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Participate in and support audits according to QMS ISO 13485 and 21 CFR 820
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Lead or contribute to continuous improvement initiatives within the regulatory function
Your profile
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University degree in Engineering, Natural Sciences, Medical Sciences, or equivalent professional experience
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Minimum 5 years of professional experience in Regulatory Affairs, ideally with combination products and/or medical devices
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Previous experience with FDA (e.g. 510k submission) and application of artificial intelligence is a plus
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Strong organizational and interpersonal skills with a proactive mindset
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Fluent in English (C1) 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.
Contact
Alain Rusconi
Human Resources Expert Recruiting
+41 (0) 34 424 28 64
Your future place of work
Burgdorf