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
Atlanta, GA office.
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.
This position's reasonably anticipated salary range is $148,000-$195,000 annually. 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.
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!
