International RA Manager Medical Devices

Our customer is one of the leading companies in the areas of intensive care. More than half of the employees work at the headquarters for development and production in Switzerland. For the second time in a row our customer received the Top Company award from the most important rating portal in Germanspeaking countries.

To support the RA team for a broad portfolio of ventilation monitoring and recording accessories and consumables we are seeking to onboard a new RA Manager in a hybrid working model or location to chose in Switzerland or Germany.

Your tasks:
In the role of Manager Regulatory Affairs you will be responsible for daytoday business in the area of regulatory affairs for these medical devices.

• Compliance with regulatory requirements during conception and development production as well as during market observation of the products.
• Knowledge of normative and regulatory framework
• Application of standards (IEC 606011 ISOIEC 62304 etc.) to our products and processes
• International registration of medical devices worldwide with a focus on the EU and US markets

Your skills

• Education in a scientific or medicaltechnical direction.
• Experience in the field of regulatory affairs ideally from medical technology
• Knowledge of the IEC 60601 or IEC 62304 series of standards
• Working independently working in teams
• Cooperation and communication with authorities
• Languages: Fluent in English and German. Secure drafting of documents in English
• German: Motivation and willingness to learn the German language independently

We are looking for initiative and communicative personalities with a handson mentality and solution oriented mindset. Were happy if its exciting if youre on board and if we can discuss your application with the line manager.