1 job found in zug, zug

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    • zug, zug
    • temporary
    Do you have at least 5 years of experience in Regulatory Affairs in the medical device industry ? Would you like to work on global projects ? You should then read the following line!One of our clients, a renowned medical device company based in the Zug area, is looking for a Regulatory Affairs Manager for a 1 year contract (extendable).This role is 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 projectsTasks:Project Lead Regulatory, within the scope of a project for new products or during the product life cycleProvides regulatory support to the R&D Project teams with the applicable Design Control processesProvides team members ad hoc specific educationProvides qualification and classification of the development object and related submission strategyEscalates project related regulatory issues;Review of labellingAssemble the documents and the project deliverable (or coordinate the activities) for the preparation of world-wide registration and resolution of possible conflictsAdministration of Product declarations, Certificates and other, similar documentsDefine and implement necessary processes, strategies and SOPs to manage the interfaces within the assigned areaEnsure the interface function between employer and Regulatory Affairs teams for the product approval/clearance in the country of interestEducation of staff members of R&D and Portfolio Management on regulatory related topics (e.g. regulations or changes in the regulations) Profile:Bachelor or Master Degree in Life SciencesAt least 5 years of experience as a Regulatory Affairs Manager for IVD InstrumentsAt least 5 years of experience with Development of IVD Devices or Medical Devices (IVDR)Experience with software regulationsExperience in supporting development projectsVery good command of English is required Do those lines trigger your interest ? Do not waste a second and apply now!
    Do you have at least 5 years of experience in Regulatory Affairs in the medical device industry ? Would you like to work on global projects ? You should then read the following line!One of our clients, a renowned medical device company based in the Zug area, is looking for a Regulatory Affairs Manager for a 1 year contract (extendable).This role is 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 projectsTasks:Project Lead Regulatory, within the scope of a project for new products or during the product life cycleProvides regulatory support to the R&D Project teams with the applicable Design Control processesProvides team members ad hoc specific educationProvides qualification and classification of the development object and related submission strategyEscalates project related regulatory issues;Review of labellingAssemble the documents and the project deliverable (or coordinate the activities) for the preparation of world-wide registration and resolution of possible conflictsAdministration of Product declarations, Certificates and other, similar documentsDefine and implement necessary processes, strategies and SOPs to manage the interfaces within the assigned areaEnsure the interface function between employer and Regulatory Affairs teams for the product approval/clearance in the country of interestEducation of staff members of R&D and Portfolio Management on regulatory related topics (e.g. regulations or changes in the regulations) Profile:Bachelor or Master Degree in Life SciencesAt least 5 years of experience as a Regulatory Affairs Manager for IVD InstrumentsAt least 5 years of experience with Development of IVD Devices or Medical Devices (IVDR)Experience with software regulationsExperience in supporting development projectsVery good command of English is required Do those lines trigger your interest ? Do not waste a second and apply now!

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