GRA Device Lead, Raleigh, NC

UCB•Raleigh, NC

1d•$148,000 - $195,000•Hybrid

About The Position

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.

Requirements

Master’s degree
Minimum of 10 years of medical device experience in life science and/or pharma.

Nice To Haves

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.

Responsibilities

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.