As a preferred supplier for Roche Diagnostics in Rotkreuz near Zug, we are looking for a personality as Regulatory Affairs Manager (contract for 1 year, with extension if it is a fit for all parties) start date within 1-2 months. Remote/Home Office is possible.
1) Project Lead Regulatory, within the scope of a project for new products or during the product lifecycle:
• Provides regulatory support to the R&D Project teams with the applicable Design Control processes
• Provides team members ad hoc specific education;
• Provides qualification and classification of the development object and related submission strategy;
• Interfaces with the correspondent RA-FL for submission strategies, planning and support;
• Escalates project related regulatory issues;
• Review of labelling
• Assemble the documents and the project deliverable (or coordinate the activities) for the preparation of worldwide registration and resolution of possible conflicts.
• Administration of Product declarations, Certificates and other, similar documents
2) Global Regulatory Affairs Manager - interaction with other regulatory functions:
• 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
3) Global Regulatory Affairs Manager - interaction with functions other than regulatory functions:
• Education of staff members of R&D and Portfolio Management on regulatory related topics (e.g. Regulations or changes in the regulations).
• Accomplish of conformity evaluation including compilation of the conformity declaration for new and existing products.
• Provide support for specific topic/questions
4) Global Regulatory Affairs Manager-General Task
• Define and provide Training on Regulatory submission topics
• Monitor regulatory requirements, including communication and distribution in a level appropriate manner
• Implementation of divisional and local-strategies
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• Minimum 3/4 years in hands regulatory affairs in in vitro diagnostic medical devices
• Experience in industry
• Experience with hard and soft wares (working with instruments)
• Scientific degree (microbiology or chemistry) or an engineering degree
• RWD knowledge / understanding
• Excellent communications and negotiations skillsApplication process
Interested? You can find more information here Link . Apply online via the "Apply" link at the top right. Please answer all questions, without them we cannot process your application.
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