Regulatory Affairs Manager

Would you like to work in a dynamic and fast growing environment? Then apply and join a highly motivated and innovative Regulatory Affairs team at our Burgdorf site as

Regulatory Affairs Manager | 80 - 100%

Ref. No. 7401

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

• Manage regulatory responsibilities associated with the development, support, and deployment of combination products and medical devices within the business area delivery systems
• Manage the development and implementation of regulatory strategies
• Support of development projects with a focus on regulatory aspects
• Support and prepare worldwide product submission documents
• Partner with business stakeholders on different levels
• Support life-cycle management activities
• Support in QMS ISO 13485 and 21 CFR 820 audits
• Lead or support continuous improvement initiatives

Your profile

• Available within Q1 of 2025
• University degree preferably in Engineering or Natural/Medical Sciences or equivalent experience
• At least 5 years of professional experience in Regulatory Affairs with focus on combination products and/or medical device
• Previous experience with sterile medical devices is a plus
• Excellent organizational and interpersonal skills
• Ability to communicate effectively with different stakeholders and on different levels
• Very good English knowledge (Level C2 or MT); Good German knowledge (Level B1 or B2)

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