For our customer, the world leader in IVD, located in Rotkreuz, we are looking for a RA expert, with knowledge in SW regulations
Regulatory Affairs Manager
In this function, you will be responsible for activities associated with regulatory approval of in vitro diagnostic medical devices including the overall development, implementation and coordination of regulatory strategies and activities with a focus on hardware and software products and projects. Further you will be responsible for assessment of device changes for regulatory implications.
- Provides regulatory support to the R&D Project teams with the applicable Design Control processes
- Ensure the interface function between employer and Regulatory Affairs teams for the product approval/clearance in the country of interest.
- Inform Global Regulatory Affairs Business areas about changes
- Inform Global Regulatory Affairs Business areas about relevant issues during product development and life cycle management
- Monitor regulatory requirements, including communication and distribution in a level appropriate manner
- Implementation of divisional and local-strategies
- Master degree in Life Science or Engineering degree
- Min 3 years in hands-on global regulatory affairs
- Experience in global regulatory affairs working on development projects in medical devices (MD or IVD)
- Experience in industry
- Experience with software (working with instruments)
- RWD knowledge / understanding
Please apply online. For further information about the position, please contact your Kelly recruiter, Mr. Andreas Danner, Dr. med. Dipl.-Biol. (+41 44 225 41 07/ +41 76 310 760 9.
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