Regulatory Affairs Manager

vor 2 Wochen

Rotkreuz, Schweiz Work Selection Vollzeit

**Beschreibung**:
For our international partner, Roche Diagnostics International Ltd. based in Rotkreuz, we are looking for a qualified and motivated **Regulatory Affairs Manager** for one year with option for extension.

This Regulatory Affairs function belongs to the Roche Core Lab Customer Segment Automation. As Regulatory Affairs they support instrument and systems projects and the related product portfolio.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 projects. Responsible for assessment of device changes for regulatory implications.

**Tasks**:

- 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
- 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

**Must Haves**:

- Bachelor or Master Degree in Life Sciences or Engineering
- At least 5 years of experience as a Regulatory Affairs Manager in IVD Instruments
- At least 5 years of experience with Development of IVD Devices
- Regulatory Affairs experience with software development
- Experience with risk management
- Very good command of English is required

**Nice to Haves**:

- German language skills
- Experience with electrical medical devices
- Hardware and software of IVD instruments

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