GRA Device Lead, Brussels, Belgium

Make your mark for patients 

We are looking for a Global Regulatory Affairs (GRA) Device Lead who is strategic, collaborative, and regulatory focused to join us in our Regulatory CMC & Devices team, based in our Raleigh, NC or Brussels, Belgium offices.

About the role

The Global Regulatory Affairs Devices Lead supports regulatory strategy and submissions for marketed and development medical devices and combination products within Neurology, Immunology, and New Medicines, particularly for cell and gene therapies. The role covers device types such as drug delivery systems, IVDs, and biomarkers.

You will help develop global regulatory strategies, prepare device documentation and submission content, support timely approvals, contribute to health authority and notified body interactions, and provide regulatory input to cross-functional initiatives and business priorities.

Who you’ll work with

You’ll work closely with the GRA Device Lead and collaborate with Global Clinical Development, Global Clinical Science and Operations, Patient Supply, and Device and Primary Packaging Development. You will also partner across the internal matrix organization and engage with health authorities and notified bodies on device matters as needed for assigned projects and products.

What you’ll do

• Lead global regulatory strategy and submissions for assigned device projects/products.

• Prepare and maintain device Technical Documentation Files for regulatory clearances.

• Support Health Authority and Notified Body interactions on device matters.

• Identify required device documents and align delivery with project timelines.

• Provide lifecycle management support to maintain device regulatory compliance.

• Contribute to internal regulatory initiatives and cross-functional workstreams.

Interested? For this role we’re looking for the following education, experience and skills

Minimum Qualifications

Master’s degree

Minimum of 10 years of medical device experience in life science and/or pharma.

Preferred Qualifications

Experience with marketed and development-stage medical devices and combination products.

Knowledge of global regulatory submissions, technical documentation, and approvals.

Experience with CE Mark, Notified Body, and/or FDA regulatory processes.

Strong regulatory strategy, risk assessment, and communication skills.

Ability to influence and collaborate across cross-functional teams.

Experience with drug delivery systems, IVDs, biomarkers, or related devices.

Familiarity with neurology, immunology, or new medicines portfolios.

Experience supporting global health authority and notified body interactions.

Knowledge of lifecycle management, including product changes and improvements.

Ability to leverage regulatory intelligence to drive innovative solutions.

Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities.

At UCB, we’ve embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description, this role is hybrid with 40% of your time spent in the office, irrespective of your current contractual agreement. Should your current working arrangements differ, please contact your Talent Partner to discuss, before submitting your application.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com . Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

 

Requisition ID: 93694

Recruiter: Kelly Dickinson

Hiring Manager: Meggan Czapiga

Talent Partner: Bianca Hinshaw

Job Level: MM I

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