Global Regulatory Affairs Device Lead, (Raleigh, NC)

UCB • Raleigh, NC

4d • Hybrid

About The Position

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.

Requirements

• Master’s degree.
• Minimum of 10 years of Medical Device experience in Life Science or institutional/academic setting.
• Skilled in influencing across matrixed teams and engaging external stakeholders and strategic partners.
• Ability to interpret regulatory guidelines and understand how devices are used in pre-clinical and clinical development.

Nice To Haves

• Experience with gene/cell therapies
• Experience leading global teams to execute regulatory strategies.
• Experience in neurology, CNS space.
• Demonstrated success in developing innovative, lifecycle‑focused regulatory strategies.
• Competence in regulatory risk assessment and mitigation planning.

Responsibilities

• 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.
• Accountable for preparing and maintaining DEVICES Technical Documentation Files aimed to obtain CE Marks, NBs Opinions and / or FDA clearance on assigned projects.
• Interacts with HAs/NBs.
• 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.
• Identifies supporting DEVICES documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
• Ensures Life Cycle Management support (i.e. Changes/Deviations/improvements) to maintain regulatory compliance of approved DEVICES.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level