Device Documentation Lead (Remote – Belgium Based)
Are you passionate about precision, documentation, and regulatory excellence? UCB is looking for a Device Documentation Lead to support the creation of high-quality documentation for a Drug-Device Combination Product currently in development. This is your opportunity to contribute meaningfully to global healthcare—right from Belgium.
What You’ll Do
Author and review scientific protocols, technical files, and source reports for regulatory submissions.
Manage documentation for drug delivery devices under development in collaboration with UCB partners.
Coordinate regulatory submissions, supporting cross-functional teams in compiling and approving reports.
Ensure data integrity across documentation and regulatory dossiers.
Work closely with regulatory, quality, technical, and safety experts in a global, cross-functional setting.
What You Bring
Master’s degree in a relevant scientific or technical field.
8+ years in medical devices and/or drug-device combination products.
Strong command of EU MDR, ISO 13485, GSPR, 21CFR 820 & 4, Art 117, and GMP.
Experience in documentation management, regulatory writing, and project coordination.
Fluent English writing skills, with a sharp eye for detail and compliance.
A collaborative, autonomous, and structured approach—qualities highly valued in Belgian work culture.
Why This Role is Ideal for Belgium-Based Professionals
Belgium is a leader in pharmaceutical and medical device innovation. This remote role allows you to work from within Belgium while contributing to global regulatory excellence and product development. Expect a role that combines precision, teamwork, and international collaboration.
Apply today and become a key part of bringing life-changing therapies to patients—starting with the right documentation.