GRA Device Lead, Raleigh, NC

About the role

The Global Regulatory Affairs (GRA) Device 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.

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.

Requirements

• Master’s degree in relevant field.
• 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.

Pay

The actual salary offered will consider internal equity and may also vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience, among other factors.

Schedule

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.