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* Manage regulatory responsibilities associated with the development, support, and deployment of combination products and medical devices within the business area delivery systems
* Manage the development and implementation of regulatory strategies
* Support and prepare worldwide product submission documents
* Partner with business stakeholders on different levels
* Review quality agreements with customers on regulatory aspects
* Cooperation in QMS ISO and CFR audits
* Lead or support continuous improvement initiatives
Your profile
* University degree preferably in Engineering or Natural/Medical Sciences or equivalent experience
* At least 2 years of professional experience in Regulatory Affairs with focus on combination products and/or medical devices
* Excellent organizational and people skills
* Ability to work in an international cross-functional organization
* Very good English knowledge (C2), German is a plus (B1)
Your main tasks
* Manage regulatory responsibilities associated with the development, support, and deployment of combination products and medical devices within the business area delivery systems
* Manage the development and implementation of regulatory strategies
* Support and prepare worldwide product submission documents
* Partner with business stakeholders on different levels
* Support life-cycle management activities
* Review quality agreements with customers on regulatory aspects
* Cooperation in QMS ISO and CFR audits
* Lead or support continuous improvement initiatives
Your benefits
* Shiftwork, annual working hours, part-time
* Work where and when you want (in Switzerland)
* Up-to-date production, offices, break areas
* Ypsomed covers % of the pension contributions
* Charging stations, Swiss Half Fare Card, parking, close to public transport
* Affordable or free gyms all over Switzerland
* Financial contributions to childcare
About Ypsomed
Ypsomed - making the treatment of chronic diseases possible. More than 2, 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.
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