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)
Your benefits
Pension fund
Ypsomed covers 55% of the pension contributions
Mobility support
Charging stations, Swiss Half Fare Card, parking, close to public transport
Free sport facilities
Affordable or free gyms all over Switzerland
Family friendly
Financial contributions to childcare
Working hours
Shiftwork, annual working hours, part-time
FlexWork
Work where and when you want (in Switzerland)
Up-to-date work environment
Up-to-date production, offices, break areas
Your Ypsomed work environment
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
Human Resources Expert Recruiting
+41 (0) 34 424 28 64