Passion.
Ypsomed. Would you like to work in a dynamic and fast-growing environment? Then apply and join a highly motivated and innovative Regulatory Affairs team at our Burgdorf site as
Regulatory Affairs Manager | 80 - 100%
Ref. No. 7401 Location: Burgdorf | Hybrid
Help us bring to market state-of-the-art medical technology solutions by optimizing processes and ensuring quality through your structured approach.
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 development projects with a focus on regulatory aspects.
* Support and prepare worldwide product submission documents.
* Partner with business stakeholders on different levels.
* Support life-cycle management activities.
* Support in QMS ISO 13485 and 21 CFR 820 audits.
* Lead or support continuous improvement initiatives.
Your profile
* Available within Q1 of 2025.
* University degree preferably in Engineering or Natural/Medical Sciences or equivalent experience.
* At least 5 years of professional experience in Regulatory Affairs with focus on combination products and/or medical devices.
* Previous experience with sterile medical devices is a plus.
* Excellent organizational and interpersonal skills.
* Ability to communicate effectively with different stakeholders and on different levels.
* Very good English knowledge (Level C2 or MT); Good German knowledge (Level B1 or B2).
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 55% 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.
Your Ypsomed work environment
Ypsomed - making the treatment of chronic diseases possible. 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 despite chronic diseases such as diabetes, obesity, or certain types of cancer, providing them with the greatest possible quality of life.
Contact
Alain Rusconi
Human Resources Expert Recruiting +41(0)344242864#J-18808-Ljbffr