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Medical Device Regulatory Scientist, Slough
Client: UCB
Location: Slough, United Kingdom
Job Category: -
EU work permit required: Yes
Job Reference: 05844a7e1e83
Job Views: 7
Posted: 24.04.2025
Expiry Date: 08.06.2025
Job Description:
Make your mark for patients
We are looking for a Medical Device Regulatory Scientist to join our Global Regulatory Affairs team, based in Brussels (Belgium), Bulle (Switzerland), or Slough (UK).
The Medical Device Regulatory Scientist will handle regulatory activities for marketed and developmental medical devices and combination products within the Neurology, Immunology, and New Medicines units.
Responsibilities include:
* Align with global regulatory strategy to plan, prepare, review, and approve submissions for device components of combination products to ensure timely approvals.
* Prepare and maintain Technical Documentation Files to obtain CE Marks, Notified Body opinions, and FDA clearance.
* Interact with Health Authorities.
* Support global CMC regulatory strategies consistent with company practices and goals.
* Identify required device documents for submissions and coordinate their delivery to meet project timelines.
* Maintain regulatory compliance through Life Cycle Management activities such as changes, deviations, and improvements.
Qualifications and Skills:
* Knowledge of drug and medical device manufacturing processes.
* Understanding of GMP/ISO standards and change management systems.
* Familiarity with IVD, MDR, 510K, and IMDRF requirements.
* Experience working in cross-functional teams within a matrix organization.
* Ability to integrate medical device expertise into global regulatory strategies.
* Skills in synthesizing technical data for documentation and submissions.
* Knowledge of drug delivery products like syringes, inhalers, patches, and pumps.
If you want to learn more about R&D at UCB, please find more information here.
RANDATUCB
Are you ready to ‘go beyond’ to create value and make your mark for patients? If so, we would love to hear from you!
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