Device Documentation Specialist (CH)

We are lookingforaDevice DocumentationSpecialistwho ismethodical detail-oriented with excellent interrelation skillsto join us in our Devices Artwork and Packaging(DAP)team.

The position can be based in one of our campuses in Braine lAlleud (BE)orBulle (CH).

About the Role

This role operates within crossfunctional technical project teams responsible for the design developmentindustrializationand life cycle managementof drugdevice combination Device DocumentationSpecialistsupports device development programs by coordinating documentation activities trackingkeydeliverables and ensuring the integrity consistency and availability of development data required for design reviews and regulatory submissions.

Who youll work with

Reporting to theHead of Device Transversal Services you will act as adocumentation and project support specialist partnering with technical teams project leaders and regulatory stakeholders to support device and packaging documentation activities. You will help ensure thatdevelopment documentationandproject deliverablesremain organized traceable and aligned with project timelines and submission requirements.

What Youll Do

Documentation & DeliverablesCoordination:

• Support documentationactivities across drug-device combination product development programs.

• Maintain and track documentationplans and deliverables in alignment with project timelines and key development milestones.

• Coordinatethe collection organization and consolidation of technical documentation required for Design Reviews and regulatory submissions.

• Monitordocumentation readiness and escalate potential delays gaps or inconsistencies to project teams.

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

Data Integrity & DocumentationQuality:

• Perform documentationconsistencyandcompletenesschecks across device and packaging development records.

• Supportdata integrityactivities by verifying that documentation is accurate traceable and aligned across multiple sources.

• Assist in identifyingdocumentation gaps missing information ordiscrepanciesthat may impact project deliverables.

• Maintaindocumentation trackersanddashboardsto provide visibility on deliverable status and readiness.

• Contributeto the implementation ofdocumentation managementanddata governancebest practices.

Cross-Functional ProjectSupport:

• Collaboratewith technical SMEs project leaders quality regulatory and external partners tocoordinate documentationactivities.

• Organizeandfacilitate documentation review meetings follow-up actions and status updates.

• Supportproject teams inplanningandtrackingdocumentation-related activities and deliverables.

• Provide regularupdatesondocumentation progressrisksandreadinessto stakeholders.

ContinuousImprovement:

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

• Supportinitiatives to improve documentation processes data management and deliverable tracking.

• Participatein digitization and process improvement projects related to device and packaging documentation.

• Promoteconsistent documentation practicesacrossdevelopmentprograms.

Interested For this role were looking for the following education experience and skills

Education &Experience:

• Bachelors orMasters degree in Engineering Life Sciences Pharmaceutical Sciences or a related discipline.

• 3-7 years of experience in medical devices drug-device combination productsand/orpharmaceuticals.

• 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 ofdrugdelivery device regulatory frameworks includingEU MDRArticle 117GSPR21 CFR Part 82021 CFR Part 4ISO 13485 andGMPrequirementsisan advantage.

Skills &Competencies:

• Strongorganizationalandcoordinationskills.

• Attention todetailand ability to managemultipledeliverables simultaneously.

• Ability totrackprogress andmaintainaccurate project documentation.

• Effectivecommunicationand stakeholder-management skills.

• Collaborativemindset and ability to work within cross-functional teams.

• Proficiency withdocumentmanagement systems andprojecttracking tools.

• Structuredandproactiveapproach toproblem solving.

• Interest indrug-device combinationproduct development.