Regulatory Affairs Manager (m/f/d)
For our international medical partner, Roche Diagnostics Int Ltd based in Rotkreuz, we are looking for a qualified and motivated Regulatory Affairs Manager for one year with option for extension.
Roche Diagnostics International Ltd in Rotkreuz is one of the world’s leading providers of diagnostic system solutions for clinics, laboratories and doctors’ offices. The company employs over 2200 people in Rotkreuz and is one of Roche Diagnostics main sites.
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.
Due to a high workload, the team is looking for an additional team member. This person should have minimum 3/4 years of experience in regulatory affairs: in in vitro diagnosis devices. (Please note here experience with non-in vitro medical devices will not be enough and not considered). This experience should be from the industry (no academics). We need someone with experience with hard and software regulations as well (experience with instruments rather than liquids or active substance).
New regulations were implemented and will be coming in full effect by next year (IVDD vs IVDR to be implemented). The team is looking for support on this specific task, which will include a lot of documentations and updates. Someone with experience on implementing these new regulations would be good. On a soft skill note, we need someone with excellent communications skills able to simplify complex subjects and someone with very good negotiation skills.
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
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
- 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
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
- Minimum 3/4 years in hands regulatory affairs in 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 skills
Are you interested? Do not hesitate and submit your complete application documents online today.
We value diversity and therefore welcome all applications – regardless of gender, social origin, religion/belief, age or identity.
We also process applications by post, but will not return them for administrative reasons. We look forward to hearing from you!