For our customer, a global provider for diagnostic system solutions we are looking for the site in Rotkreuz for a
Regulatory Affairs Manager - in vitro diagnostic devices
- implementation, documentation and update of new IVDR regulations
- Define and provide Training on Regulatory submission topics
- Monitor regulatory requirements, including communication and distribution in a level appropriate manner
- Provides regulatory support to the R&D Project teams with the applicable Design Control processes
- Provides qualification and classification of the development object and related submission strategy
- Review of labelling
- Administration of Product declarations, certificates and other documents
- min 2 years experience in regulatory affairs in the area of in vitro diagnostic medical devices
- Experience with hard and soft wares (working with instruments)
- Scientific degree (microbiology or chemistry) or an engineering degree
- RWD knowledge / understanding
- Excellent communications and negotiations skills
Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Simone Mumbauer, PhD (+41 44 225 41 12).
We connect people to jobs in ways that enrich lives. Kelly Services® is a leading global provider of human resources solutions, operating in over 40 countries. Together with its subsidiaries, Kelly offers a wide range of outsourcing and consulting services; temporary, permanent and management positions as well as flexible forms of employment at all hierarchy levels. Kelly Services (Schweiz) AG has been present in Switzerland since 1979 and counts more than 200 employees in over 40 Talent Offices and Centers.