Job Description
Your Main Tasks
* Support the development of Diabetes Care solutions, focusing on active and connected devices.
* Develop and implement regulatory strategies to ensure compliance with EU and US regulations.
* Prepare and submit product documentation for regulatory approval in EU and US markets.
* Collaborate with business stakeholders at various levels to drive project success.
* Maintain communication and correspondence with authorities to ensure smooth regulatory processes.
* Participate in QMS ISO and CFR audits to ensure quality management systems are in place.
* Perform general quality management tasks, including creation of quality documents and training.
Your Profile
* University degree in Engineering or Natural/Medical Sciences, or equivalent experience.
* A minimum of 4 years of professional experience in Regulatory Affairs, with a focus on medical devices.
* Expertise in Active Medical Devices related regulations and guidance documents in EU and US.
* Excellent organizational and people skills.
* Proficient English language skills (Level C2 or higher).
Why Work with Us?
* Shiftwork, annual working hours, and part-time options available.
* FlexWork policy allows you to work from anywhere within Switzerland.
* Up-to-date production facilities, offices, and break areas.
* Pension fund contributions covered by Ypsomed.
* Convenient mobility support, including charging stations and public transport access.
* Free sport facilities and affordable gyms across Switzerland.
* Family-friendly policies, including financial contributions to childcare.
About Ypsomed
Ypsomed is a leading global company that develops and produces injection and infusion systems for self-medication. Our mission is to make the treatment of chronic diseases possible, providing people worldwide with the greatest possible quality of life despite conditions like diabetes, obesity, or certain types of cancer. With over 200 employees globally, we operate in multiple countries and offer a dynamic work environment with opportunities for growth and development.