Medical Device Regulatory Specialist
6 days ago
Make a Lasting Impact on Patient Care
We are seeking a highly skilled Medical Device Regulatory Specialist to join our Global Regulatory Affairs team at UCB. This role will be based in one of our European offices, including Brussels (Belgium), Bulle (Switzerland), or Slough (UK).
The Medical Device Regulatory Specialist will be responsible for regulatory activities for marketed and development medical devices and combination products within the scope of the Neurology, Immunology, and New Medicines units.
Key Responsibilities:
- Develop and implement global regulatory strategies for device constituents of combination products, ensuring timely approvals to meet business needs.
- Prepare and maintain Technical Documentation Files to obtain CE Marks, NBs Opinions, and/or FDA clearance for assigned projects.
- Collaborate with Health Authorities to ensure regulatory compliance.
- Support the global CMC regulatory strategy for assigned projects/products, ensuring consistency with global regulatory affairs practice, missions, goals, and objectives.
- Identify and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Ensure Life Cycle Management support to maintain regulatory compliance of approved devices.
Requirements:
- Bachelor's degree in a relevant field.
- Knowledge of drugs/medical devices manufacturing processes.
- Understanding of GMP/ISO requirements and standard systems.
- Knowledge of IVD, MDR, 510K, IMDRF requirements.
- Proven ability to contribute to cross-functional teams and operate within a matrix organizational structure.
- Ability to synthesize technical information and data to author medical devices technical documentation, CTD Module 3, and briefing books.
- Knowledge of drug delivery products.
UCB is a global biopharmaceutical company dedicated to the discovery and development of innovative medicines and solutions to transform patients' lives. If you are passionate about making a difference in the lives of patients, we encourage you to apply for this exciting opportunity.
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