Device Documentation Specialist (CH)

UCB; Bulle; Hybrid; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

UCB in Switzerland seeks a Device Documentation Specialist to support device development programs by coordinating documentation activities and ensuring data integrity for design reviews and regulatory submissions. The role sits within the Devices, Artwork and Packaging team and reports to the Head of Device Transversal Services.

You will partner with technical teams, project leaders and regulatory stakeholders to keep documentation organized, traceable and aligned with timelines.

Qualifikationen

• Bachelor's or Master's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or 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 regulatory frameworks including EU MDR, ISO 13485, GMP is advantageous.

Aufgaben

• Maintain and track documentation plans and deliverables in alignment with project timelines and milestones.
• Coordinate collection, organization and consolidation of technical documentation for Design Reviews and regulatory submissions.
• Monitor documentation readiness and raise delays or gaps to project teams.
• Support preparation of development and submission documentation packages, ensuring documents are up to date.
• Collaborate with technical SMEs, project leaders and regulatory stakeholders to coordinate documentation activities.

Kenntnisse

Documentation coordination

Regulatory submissions

Cross-functional collaboration

Attention to detail

Project tracking tools

Ausbildung

Bachelor's or Master's degree in Engineering/Life Sciences/Pharmaceutical Sciences

Tools

Document management systems

Project tracking tools

Jobbeschreibung

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

• 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 elevate 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.
• 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.

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.
• 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 .

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