Regulatory Affairs Manager (m/f/d)
This Regulatory Affairs function belongs to the Roche Centralised and Point of Care Solutions (CPS) business area and supports in addition DIA Solution Integration and Services. As Regulatory Affairs we 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 & Responsibilities:
- 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;
- 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
- 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.
- 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
- Scientific degree (microbiology or chemistry) or an engineering degree
- Minimum 3 to 4 years in hands regulatory affairs in in vitro diagnostic medical devices is absolutely mandatory
- Experience in industry
- Experience with hard and soft wares (working with instruments)
- RWD knowledge / understanding
- Excellent communications and negotiations skills
Information for you:
- Start date: Mid-March
- Latest start date: Mid-April
- End date: One-year contract
- Extension: Not planned at the moment
- Remote / Home Office: Mostly home office
- Personal and individual advice and support
- Fair and contemporary remuneration
- Further training opportunities via Temptraining
- Once the contract expires, we support you in finding employment solutions
We look forward to receiving your application in German and English. Please send your CV and all further certificates by e-mail to Ms Saranda Berisha (firstname.lastname@example.org).