Medical Device Regulatory Scientist
Make your mark for patients
We are looking for a Medical Device Regulatory Scientist to join us in our Global Regulatory Affairs team, to be based in any of our Brussels (Belgium), Bulle (Switzerland) or Slough (UK) offices
The Medical Device Regulatory Scientist is responsible for regulatory activities for marketed and development medical devices and combinations products within the scope of the Neurology, Immunology, and New Medicines units.
As a Medical Device Regulatory Scientist, you will have the following responsibilities :
- In alignment with the global regulatory strategy, responsible for strategy, planning, definition of content, preparation, review, and approval of global submissions for device constituents of combination products in assigned projects / products to achieve timely approvals to meet business needs.
- Accountable for preparing and maintaining devices Technical Documentation Files aimed to obtain CE Marks, NBs Opinions and / or FDA clearance on assigned projects.
- Interacts with Health Authorities
- Supports the global CMC regulatory strategy for assigned projects / products is consistent with global regulatory affairs practice, missions, goals, and objectives.
- Identifies supporting devices documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
- Ensures Life Cycle Management support (i.e., Changes / Deviations / improvements) to maintain regulatory compliance of approved devices
Interested? For this position you’ll need the following education , experience and skills :
- Bachelor’s degree
- Knowledge in drugs / medical devices manufacturing processes
- Knowledge of GMP / ISO requirements and standard systems (e.g. change management systems and tools)
- Knowledge of IVD, MDR, 510K, IMDRF requirements
- Demonstrated competence in contributing on cross-functional teams and operating within a matrix organizational structure.
- Ability to input medical devices expertise into the global regulatory strategy and global planning, to indemnify the critical issues and share lessons.
- Ability to synthetize technical information and data to author medical devices technical documentation, CTD Module 3 and briefing books to be submitted to Health Authorities and Notified Bodies
- Knowledge of drug delivery products (syringes, inhalers, patches, pumps).
If you are interested to learn more about R&D within UCB, please find more information here .
RANDATUCB
Are you ready to go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!
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