For our customer, the world leader in IVD, located in Rotkreuz, we are looking for a RA expert with knowledge in SW and EU (IVDR) regulations, as
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.
This position will be focused on project support for digital products, so regulatory expertise in the field of regulated SW is a must. We are looking for candidates with good knowledge of the EU (IVDR) and some insights into international registration. Experience in assuming a regulatory role within a development project is needed.
- Provide regulatory support to the R&D Project teams with the applicable design control processes
- Ensure the interface function between employer and RA teams for the product approval/clearance in the country of interest.
- Inform global RA business areas about changes
- Inform global RA 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
- Degree in life science, engineering or programming discipline
- 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
- Fluency in Spanish a plus
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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