In the Business Area Diabetes Care in Solothurn we are looking for an experienced skilled personality as a

Regulatory Affairs Manager | 100%

Ref. No. 6448

Location: Solothurn | 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

• Focus of this position is supporting our rapidly developing Diabetes Care (active and connected devices)
• Manage the development and implementation of regulatory strategies
• Support and prepare product submission documents with main focus on EU and US
• Partner with business stakeholders on different levels
• Communication and correspondence with authorities
• Cooperation in QMS ISO 13485 and 21 CFR 820 audits
• General QM tasks (Creation of Q-documents, trainings etc.)

Your profile

• University degree preferably in Engineering or Natural/Medical Sciences or equivalent experience
• At least 4 years of professional experience in Regulatory Affairs with focus medical device
• Expertise in Active Medical Devices related regulations and guidance documents in EU and US
• Excellent organizational and people skills
• Very good English knowledge (Level C2 or MT)

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

Solothurn