Regulatory Affairs Specialist for Medical Devices
vor 1 Woche
We are seeking a highly skilled Medical Device Regulatory Scientist to join our Global Regulatory Affairs team in Brussels, Bulle, or Slough.
This role involves regulating activities for marketed and development medical devices and combinations products within the Neurology, Immunology, and New Medicines units.
Key responsibilities include:
- Developing and implementing global regulatory strategies to achieve timely approvals for device constituents of combination products.
- Preparing and maintaining Technical Documentation Files for CE Marks, NBs Opinions, and FDA clearance.
- Interacting with Health Authorities and supporting the global CMC regulatory strategy.
- Identifying required supporting devices documents and negotiating their delivery within project timelines.
- Maintaining regulatory compliance through Life Cycle Management support.
To succeed in this role, you will need:
- Bachelor's degree.
- Knowledge of drugs/medical devices manufacturing processes.
- Understanding of GMP/ISO requirements and standard systems.
- Expertise in IVD, MDR, 510K, and IMDRF requirements.
- Able to contribute to cross-functional teams and operate within a matrix organizational structure.
- Ability to synthesize technical information and author medical devices technical documentation.
- Knowledge of drug delivery products.
UCB offers a dynamic and collaborative work environment. If you are passionate about regulatory affairs and committed to making a difference in patients' lives, we encourage you to apply.
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