We are looking for a Device Documentation Lead who is methodical, detail‑focused, and quality‑driven to join our Devices, Artwork & Packaging (DAP) team, supporting the development and lifecycle of drug–device combination products. This role can be based in Braine‑l’Alleud, Belgium or Bulle, Switzerland .
About The Role
As Device Documentation Lead, you will play a key role in ensuring that robust, compliant documentation supports the development and regulatory submission of drug–device combination products. You will define and implement documentation strategies across multiple programs, ensuring consistency, accuracy, and readiness for design reviews and regulatory dossiers.
Working within cross‑functional technical project teams, you will contribute across the full product lifecycle—from development and usability studies to submission, launch, and lifecycle management—ensuring high‑quality documentation that ultimately supports patient needs.
Who You’ll Work With
You will report to the Head of Device Transversal Services and collaborate closely with stakeholders across technical development, quality, regulatory, safety, and project management functions. You will also interact with external partners to ensure aligned and timely delivery of documentation for regulatory submissions.
What You’ll Do
Lead and manage device and packaging documentation activities across development programs.
Ensure documentation readiness and alignment for design reviews and regulatory submissions.
Author, review, and approve technical and scientific documentation in line with regulatory requirements.
Define and implement documentation strategies to ensure consistency across programs.
Coordinate documentation activities across cross‑functional teams and stakeholders.
Identify gaps and risks in documentation and implement mitigation actions.
Ensure compliance with QA, GMP, and regulatory requirements, including data integrity standards.
Lead documentation‑related planning, tracking, and project coordination activities.
Develop and maintain procedures, guidance documents, and best practices.
Support continuous improvement and digital transformation of documentation processes.
Interested? For this role we’re looking for:
Master’s degree in a scientific or engineering discipline.
Strong knowledge of medical device and pharmaceutical regulatory frameworks (e.g. EU MDR, GMP, ISO standards).
Proven experience delivering documentation for design reviews and regulatory submissions.
Strong project management, communication, and stakeholder‑influencing skills in global, matrix organisations.
UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
#J-18808-Ljbffr