Referenznummer: 442607/1 Startdatum: asap Projektdauer: 5 MM Ort: Rotkreuz
Manage the regulatory activities and support the product care activities of the existing and authorized product portfolio within SIS Workflow and IT Software/Hardware Projects
Communicate regulatory risks and challenges to project teams and interfaces with the lifecycle team
Consultancy and active support of the R&D project teams during the development of new products and the product lifecycle
Accomplish conformity evaluation for new and existing devices
Planning of deliverables with other Regulatory Affairs professionals for product registrations, including compilation of corresponding software and hardware reports
Provide insights into upcoming regulatory changes and trends prior to the issuance of new guidance, standards, laws or regulations (MDR/IVDR)
Bachelor or Master with technical or electrical background
Extensive experience as Regulatory Affairs Manager in electrical medical devices
Experience in development and software of IVDR Instruments
Mechanical / Electrical expertise
Fluent English language skills
Spanish and German language skills are beneficial
Working in an international renowed company in the medical technology
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