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Regulatory Strategy Manager
vor 2 Monaten
About the Role
We are seeking a highly skilled Regulatory Affairs Manager to join our team at Ypsomed. As a key member of our regulatory team, you will play a critical role in supporting our rapidly developing Diabetes Care business.
Main Responsibilities
- Develop and implement regulatory strategies to ensure compliance with EU and US regulations.
- Manage the preparation and submission of product documentation to regulatory authorities.
- Collaborate with business stakeholders to ensure regulatory requirements are met.
- Communicate effectively with regulatory authorities and respond to queries.
- Contribute to the development and maintenance of our Quality Management System (QMS).
About You
To be successful in this role, you will have:
- A university degree in a relevant field, such as Engineering or Natural/Medical Sciences.
- At least 4 years of experience in Regulatory Affairs, with a focus on medical devices.
- Expertise in EU and US regulations and guidance documents related to active medical devices.
- Excellent organizational and communication skills.
- Very good English language skills (C2 or MT level).
About Ypsomed
Ypsomed is a successful, rapidly growing, family-owned company headquartered in Switzerland. We develop and produce injection and infusion systems for self-medication, enabling people worldwide to self-treat chronic diseases. Our market-leading products and solutions provide the greatest possible quality of life for people with conditions such as diabetes, obesity, and certain types of cancer.
