Device Documentation Specialist (CH)

Make your mark for patients 

We are looking for a  Device Documentation Specialist  who is  methodical, detail-oriented, with excellent interrelation skills  to join us in our Devices, Artwork and Packaging (DAP) team.

The position can be based in one of our campuses in Braine l’Alleud (BE), or Bulle (CH).

About the Role

This role operates within cross ‑ functional technical project teams responsible for the design, development, industrialization and life cycle management of drug–device combination products. The  Device Documentation Specialist  supports device development programs by coordinating documentation activities, tracking key deliverables, and ensuring the integrity, consistency and availability of development data required for design reviews and regulatory submissions.

Who you’ll work with

Reporting to the  Head of Device Transversal Services , you will act as a  documentation and project support specialist , partnering with technical teams, project leaders, and regulatory stakeholders to support device and packaging documentation activities. You will help ensure that  development documentation  and  project deliverables  remain organized, traceable, and aligned with project timelines and submission requirements.

What You’ll Do

Documentation & Deliverables Coordination :

Support documentation  activities across drug-device combination product development programs.

Maintain and track documentation  plans and deliverables in alignment with project timelines and key development milestones.

Coordinate  the collection, organization and consolidation of technical documentation required for Design Reviews and regulatory submissions.

Monitor  documentation readiness and escalate potential delays, gaps or inconsistencies to project teams.

Support  the preparation of development and submission documentation packages by ensuring required documents are available and up to date.

Data Integrity & Documentation Quality :

Perform documentation  consistency  and  completeness  checks across device and packaging development records.

Support  data integrity  activities by verifying that documentation is accurate, traceable and aligned across multiple sources.

Assist in identifying  documentation gaps , missing information or  discrepancies  that may impact project deliverables.

Maintain  documentation trackers  and  dashboards  to provide visibility on deliverable status and readiness.

Contribute  to the implementation of  documentation management  and  data governance  best practices.

Cross-Functional Project Support :

Collaborate  with technical SMEs, project leaders, quality, regulatory and external partners to  coordinate documentation  activities.

Organize  and  facilitate documentation review meetings , follow-up actions and status updates.

Support  project teams in  planning  and  tracking  documentation-related activities and deliverables.

Provide regular  updates  on  documentation progress ,  risks  and  readiness  to stakeholders.

Continuous Improvement :

Contribute  to the development and maintenance of procedures, guidance documents and working practices related to device documentation activities.

Support  initiatives to improve documentation processes, data management and deliverable tracking.

Participate  in digitization and process improvement projects related to device and packaging documentation.

Promote  consistent documentation practices across development programs.

Interested? For this role we’re looking for the following education, experience and skills

Education & Experience :

Bachelor's or Master's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related discipline.

3-7 years of experience in medical devices, drug-device combination products and/or pharmaceuticals.

Experience supporting technical documentation, development projects, regulatory submissions, or quality systems.

Familiarity with design control documentation and regulated product development environments is an advantage.

Knowledge of data integrity and document management principles is desirable.

Understanding of  drug ‑ delivery device regulatory frameworks , including  EU MDR ,  Article 117 ,  GSPR ,  21 CFR Part 820 ,  21 CFR Part 4 ,  ISO 13485 , and  GMP  requirements is an advantage.

Skills & Competencies :

Strong  organizational  and  coordination  skills.

Attention to  detail  and ability to manage  multiple  deliverables simultaneously.

Ability to  track  progress and  maintain  accurate project documentation.

Effective  communication  and stakeholder-management skills.

Collaborative  mindset and ability to work within cross-functional teams.

Proficiency with  document  management systems and  project  tracking tools.

Structured  and  proactive  approach to  problem solving .

Interest in  drug-device combination  product development.

Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities.

At UCB, we’ve embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description, this role is hybrid with 40% of your time spent in the office, irrespective of your current contractual agreement. Should your current working arrangements differ, please contact your Talent Partner to discuss, before submitting your application.

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 [email protected] . Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

 

Requisition ID: 93803

Recruiter: Petra Demes

Hiring Manager: Audrey Clarembeaux

Talent Partner: Laurent Simonart

Job Level: SA II

Please consult HRAnswers for more information on job levels.