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.
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