Device Documentation Lead

Make your mark for patients

We are looking for a Device Documentation Lead who is methodical detailfocused and qualitydriven to join our Devices Artwork & Packaging (DAP) team supporting the development and lifecycle of drugdevice combination products. This role can be based in BrainelAlleud 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 drugdevice 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 crossfunctional technical project teams you will contribute across the full product lifecyclefrom development and usability studies to submission launch and lifecycle managementensuring highquality documentation that ultimately supports patient needs.

Who Youll 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 Youll 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 crossfunctional 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 documentationrelated 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 were looking for:

Masters degree in a scientific or engineering discipline.

Extensive experience in drugdevice combination product development environments.

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 stakeholderinfluencing skills in global matrix organisations.

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 dont just complete tasks we create value. We arent 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 thats 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 weve embraced a hybrid-first approach to work bringing teams together in local hubs to foster collaborative curiosity. Unless expressly 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 laws.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

Employment Type : Full Time
Experience: years
Vacancy: 1