Job Description
We are seeking a highly skilled Regulatory Affairs Specialist to join our team in managing regulatory responsibilities associated with the development, support, and deployment of combination products and medical devices.
Main Responsibilities:
* Develop and implement regulatory strategies to ensure compliance with relevant regulations and standards.
* Support and prepare worldwide product submission documents, including quality agreements with customers on regulatory aspects.
* Partner with business stakeholders at different levels to drive regulatory excellence and efficiency.
* Review and manage regulatory documents, ensuring accuracy and completeness.
* Cooperate in QMS ISO and CFR audits to maintain high standards of quality and regulatory compliance.
Your Profile:
* A university degree 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, with ability to work in an international cross-functional organization.
* Very good English knowledge (C2), German is a plus (B1).
Benefits:
* Shiftwork, annual working hours, part-time options available.
* Flexibility to work where and when you want, within Switzerland.
* State-of-the-art production facilities, offices, and break areas.
* Ypsomed covers a portion of pension contributions.
* Charging stations, Swiss Half Fare Card, parking, and close proximity to public transport.
* Affordable or free gyms throughout Switzerland.
* Financial contributions to childcare.
About Ypsomed:
Ypsomed - making treatment of chronic diseases possible. With over 200 employees worldwide, we develop and produce injection and infusion systems for self-medication. As a successful, rapidly growing family-owned company headquartered in Burgdorf (CH), we provide market-leading products and solutions to enable people globally to self-treat despite chronic diseases like diabetes, obesity, or certain types of cancer.