As a preferred supplier for Roche Diagnostics Int Ltd in Rotkreuz, we are looking for an individual as Regulatory Affairs Manager, contract until 30.06.2022, with extension if suitable for all parties, earliest start 01.07.2021 or within 3 months.
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;
- escalates project related regulatory issues;
- Review of labelling
- assemble the documents and the project deliverable (or coordinate the activities) for the preparation of world-wide registration and resolution of possible conflicts.
- Administration of Product declarations, Certificates and other, similar documents
Global Regulatory Affairs Manager
- Interaction with other regulatory functions:
- Define and implement necessary processes, strategies and SOPs to manage the interfaces within the assigned area
- Ensure the interface function between employer and Regulatory Affairs teams for the product approval/clearance in the country of interest.
- 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).
- Provide support for specific topic/questions
- Bachelor or Master Degree in Life Sciences
- At least 5 years of experience as a Regulatory Affairs Manager in IVD Instruments, electrical medical devices as a plus
- At least 5 years of experience with Development of IVD Devices, Hardware and Software of IVD Instruments as a plus
- Experience in industry
- Experience in supporting development projects
- Very good command of English is required
Nice to have:
- Experience in a regulated environment or experience in GxP
- Mechanical/Electrical Expertise