Passion.
Ypsomade.In the Business Area Diabetes Care in Solothurn we are looking for an experienced skilled personality as a
Regulatory Affairs Manager | 100%Ref. No. 6448Location:Solothurn | HybridHelp 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)
Your benefits
Pension fundYpsomed covers 55% of the pension contributions
Mobility supportCharging stations, Swiss Half Fare Card, parking, close to public transport
Free sport facilitiesAffordable or free gyms all over Switzerland
Family friendlyFinancial contributions to childcare
Working hoursShiftwork, annual working hours, part-time
FlexWorkWork where and when you want (in Switzerland)
Up-to-date work environmentUp-to-date production, offices, break areasYour Ypsomed work environment
Ypsomed - making the treatment of chronic diseases possibleMore 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.
ContactAlain Rusconi
Human Resources Expert Recruiting+41 (0) 34 424 28 64Ask a question
Your future place of work