Regulatory Affairs Manager
![Ypsomed AG Ypsomed AG](https://media.jobs.ch/images/f34a90f8-4d49-4aa6-8a62-1123906d5b89/300x150.png)
![Ypsomed AG Ypsomed AG](https://media.jobs.ch/images/f34a90f8-4d49-4aa6-8a62-1123906d5b89/300x150.png)
In the Business Area Diabetes Care in Solothurn we are looking for an experienced skilled personality as a
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.
- 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.)
- 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)
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.
Alain Rusconi
Human Resources Expert Recruiting
+41 (0) 34 424 28 64
Solothurn
Lieu de travail
Ziegelmattstrasse 1
4500 Solothurn