Global Regulatory Affairs Device Lead, (Raleigh, NC)

Make your mark for patients

Are you ready to shape the future of cuttingedge medical technologies? As the Global Regulatory Affairs Devices Lead (GRADL), 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 lifechanging technologies while driving global regulatory strategy in a highly visible, highimpact role.

This position can be located in Atlanta, GA, or Raleigh, NC.

About the Role

In this role, the Global Regulatory Affairs Devices Lead (GRADL) 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 highquality, 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 devicerelated submissions and communications meet regulatory expectations and support timely approvals across regions.

What You'll Do

• 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.

Who you'll work with

• The GRA Device Team Lead, partners closely on strategy, planning, documentation, and regulatory submissions.
• Global Clinical Development (GCD) and Global Clinical Science & Operations (GCSO) teams provide integrated regulatory input.
• Patient Supply, Device Development, and Primary Packaging Development to support device lifecycle and submission readiness.
• Health Authorities (HAs) and Notified Bodies (NBs) for global regulatory interactions, approvals, and technical documentation assessments.
• Crossfunctional partners involved in regulatory business initiatives and enterprise workstreams.
• 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

• Master's degree.
• Minimum of 10 years of Medical Device experience in Life Science or institutional/academic setting.

Preferred Qualifications

• Experience with gene/cell therapies
• Skilled in influencing across matrixed teams and engaging external stakeholders and strategic partners.

• Experience leading global teams to execute regulatory strategies.
• Ability to interpret regulatory guidelines and understand how devices are used in pre-clinical and clinical development.
• Experience in neurology, CNS space.
• Demonstrated success in developing innovative, lifecyclefocused regulatory strategies.
• Competence in regulatory risk assessment and mitigation planning.

This position's reasonably anticipated salary range is $125,600-164,900 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!

About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?
At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

At UCB, we've embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. 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.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable federal, state, or local law. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment, your employment with UCB, or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws, orders, and regulations.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.