GRA Device Lead, Raleigh, NC

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 NCoffice.

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 youll work with

Youll 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 youll 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 were looking for the following education experience and skills

Minimum Qualifications

• Masters 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.

This positions reasonably anticipated salary range is $148000-$195000 annually. The actual salary offered will consider internal equity and may also vary depending on the candidates geographic region job-related knowledge skills and experience among other factors.

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!

About us
UCB is a global biopharmaceutical company focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe inspired by patients and driven by science.

Why work with us
At UCB we dont just complete tasks we create value. We arent afraid to push forward collaborate and innovate to make our mark for patients. We have a caring supportive culture where everyone feels included respected and has equal opportunities to do their best work. We go beyond to create value for our patients and always with a human focus whether thats on our patients our employees or our planet. Working for us you will discover a place where you can grow and have the freedom to carve your own career path to achieve your full potential.

At UCB weve embraced a hybrid-first approach to work bringing teams together in local hubs to foster collaborative curiosity. Unless explicitly stated in the description or precluded by the nature of the position roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employment decisions will be made without regard to any characteristic protected by applicable federal state or local law. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment your employment with UCB or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws orders and regulations.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.