The world market leader in In vitro-Diagnostics in Rotkreuz (ZG) is looking for a RA expert with knowledge in working on industrial development projects for MDs/ IVDs and in software 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.
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
- Provide qualification & classification of the development object and related submission strategy
- Administration of product declarations, certificates and similar documents
- Ensure the interface function between employer and RA teams for the product approval/clearance in the country of interest.
- Education of R&D/ Portfolio Management on regulations or changes in regulation
- 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
- 5 years of experience as RA Manager in IVD instruments (electrical MDs as a plus)
- At least 5 years of experience with development of IVDs, hardware or software of IVD instruments as a plus
- Experience in global regulatory affairs working on development projects in medical devices (MD or IVD)
- Experience in industry
- Very good English skills
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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