Job Detail

To strengthen our Quality Assurance and Regulatory Affairs Group in Frauenfeld, we are looking for a solution oriented and creative personality as

Regulatory Affairs Specialist (m/f)

Your tasks

• Worldwide registrations of class I and III medical devices


• Assembly and maintenance of the worldwide registration documentation (STED, CSDT), provision of notarized and legalized documents


• Collaboration with our distributors for submission in the respective countries


• Manage global registrations and maintain existing registrations following changes to MDR


• Regulatory and quality projects (e.g. MDR, UDI) according to requirements in the target territories


• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review


• Analyze product complaints and make recommendations regarding their reportability

Your profile

• Degree in technical or natural sciences or business administration background; at least Applied Sciences University level


• 5 years of experience in medical device industry, preferably in international Regulatory Affairs


• Proficiency in MS Office applications


• Fluent in writing and negotiation in German and English; Know-how in further languages is of advantage


• Excellent planning and organizational skills with capability to prioritize tasks and adhere to timelines


• Team player with good communication skills


• Self-reliant, resilient, flexible, reliable, structured, sociable personality

We offer a working culture, which is based on collegiality, performance and cooperation in a young, well-established and innovative organization with a lot of pioneering spirit. Apart from challenging and varied tasks in an international setting, we offer diverse development possibilities in our dynamic and growing team.

Share with us the passion for excelling performance in the Medtech industry and forward your complete set of application documentation to: This email address is being protected from spambots. You need JavaScript enabled to view it.