Professional Regulatory Affairs Manager
Posted on Oct 8, 2019 by ITech Consult
Professional Regulatory Affairs Manager - IVDR/regulatory affairs/developer/german/spanish
For one of our clients we are looking for an Professional Regulatory Affairs Manager. The role is a contract position for 5 month at Roche Diagnostics in Rotkreuz, Switzerland.
The Regulatory Affairs team belongs to Roche Solution, Integration and Services (SIS) which is responsible for the optimization and automation of processes. The contractor we are looking for will support the Pre- and post-analysis of electrical medical devices in relation to Hardware and Software instruments. This mature regulatory role is responsible for the overall development, implementation and coordination of regulatory strategies and activities with focus on software products and projects. The Rotkreuz department is responsible for requirements related to platforms developed with internal and external partners.
- Manages the regulatory activities and supports the product care activities of the existing and authorized product portfolio within SIS Workflow and IT Software/Hardware Projects, No Assays
- Assesses and communicates regulatory risks and challenges to project teams and Interfaces with the lifecycle team (There is no contact with the regulatory authorities)
- Consultancy and active support of the R&D project teams during the development of new products and during the product lifecycle
- Accomplishes 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
- Provides insights into upcoming regulatory changes and trends prior to the issuance of New guidance, standards, laws, or regulations (MDR/IVDR)
- Ensures the interface between Roche (Rotkreuz) and Regulatory Affairs teams for Product approvals/clearances in the various regions and fulfilment of requirements
- Works in a cross-functional, multi-site team to ensure alignment and harmonization
- 5 years or more of experience as Regulatory Affairs Manager in electrical medical devices
- Experience with Development and Software of IVDR Instruments
- Mechanical/Electrical Expertise
- As a second option we would also consider someone who has experience as Software Developer
-Travelling to Stuttgart
Bachelor or Master with technical or electrical background
Reference No.: 918662SGR
Role: Professional Regulatory Affairs Manager
Location: Luzern und Region
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert
ITech Consult is a certified ISO 9001:2008 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT & Life Science candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.