Make your mark for patients
Are you ready to shape the future of cutting‑edge medical technologies? As the Global Regulatory Affairs Devices Lead (GRA‑DL), you’ll play a pivotal role in bringing innovative medical devices and combination products to patients worldwide—spanning Neurology, Immunology, and breakthrough New Medicines, including cell and gene therapies. From advanced Drug Delivery Systems to IVDs and Biomarkers, you’ll influence a diverse portfolio of life‑changing technologies while driving global regulatory strategy in a highly visible, high‑impact role.
This position can be located in Atlanta, GA, or Raleigh, NC.
About the Role
In this role, the Global Regulatory Affairs Devices Lead (GRA‑DL) partners closely with the GRA Device Team Lead to guide regulatory strategy, documentation planning, and submission preparation for medical device programs. You will collaborate with Global Clinical Development (GCD), Global Clinical Science & Operations (GCSO), Patient Supply, and Device & Primary Packaging Development to ensure high‑quality, globally aligned regulatory inputs. The position also plays a key role in shaping interactions with Health Authorities (HAs) and Notified Bodies (NBs), ensuring that all device‑related submissions and communications meet regulatory expectations and support timely approvals across regions.
What You’ll Do
1. In alignment with the global regulatory strategy, responsible for strategy, planning, definition of content, preparation, review and approval of global submissions for DEVICES in assigned projects/products to achieve timely approvals to meet business needs.
2. Accountable for preparing and maintaining DEVICES Technical Documentation Files aimed to obtain CE Marks, NBs Opinions and / or FDA clearance on assigned projects.
3. Interacts with HAs/NBs.
4. Supports the global regulatory strategy for assigned projects/products is consistent with the GRA Practice, Patient Solutions, Patient Evidence, and Patient Supply missions, goals and objectives.
5. Identifies supporting DEVICES documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
6. Ensures Life Cycle Management support (i.e. Changes/Deviations/improvements) to maintain regulatory compliance of approved DEVICES.
Who you’ll work with
7. The GRA Device Team Lead, partners closely on strategy, planning, documentation, and regulatory submissions.
8. Global Clinical Development (GCD) and Global Clinical Science & Operations (GCSO) teams provide integrated regulatory input.
9. Patient Supply, Device Development, and Primary Packaging Development to support device lifecycle and submission readiness.
10. Health Authorities (HAs) and Notified Bodies (NBs) for global regulatory interactions, approvals, and technical documentation assessments.
11. Cross‑functional partners involved in regulatory business initiatives and enterprise workstreams.
12. Teams aligned with the GRA Practice, Patient Solutions, Patient Evidence, and broader Patient Supply missions, ensuring strategic consistency across programs.
Interested? For this role we’re looking for the following education, experience, and skills
Minimum Qualifications
13. Master’s degree.
14. Minimum of 10 years of Medical Device experience in Life Science or institutional/academic setting.
Preferred Qualifications
15. Experience with gene/cell therapies
16. Skilled in influencing across matrixed teams and engaging external stakeholders and strategic partners.
17. Experience leading global teams to execute regulatory strategies.
18. Ability to interpret regulatory guidelines and understand how devices are used in pre-clinical and clinical development.
19. Experience in neurology, CNS space.
20. Demonstrated success in developing innovative, lifecycle‑focused regulatory strategies.
21. Competence in regulatory risk assessment and mitigation planning.
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!