Focus of this position:
* 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 and CFR 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 on medical devices
* 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)
Working hours:
Shiftwork, annual working hours, part-time
Your benefits:
* FlexWork: Work where and when you want (in Switzerland)
* Up-to-date work environment: Up-to-date production, offices, break areas
* Pension fund: Ypsomed covers % 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
About Ypsomed:
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-treat chronic diseases such as diabetes, obesity, or certain types of cancer, providing them with the greatest possible quality of life.
#J-18808-Ljbffr