Device Documentation Specialist - Hybrid & Regulatory-Focused

UCB

Eigenbrakel

Hybride

EUR 55 000 - 75 000

Plein temps

Il y a 11 jours

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Résumé du poste

UCB is seeking a Device Documentation Specialist to join the Devices, Artwork and Packaging team. You will coordinate development documentation and support design reviews and regulatory submissions.

Based on one of our BE or CH campuses, the role involves cross-functional collaboration with engineering, quality and regulatory to ensure data integrity and traceability. The ideal candidate has an engineering or life sciences background, 3–7 years in medical devices or pharmaceuticals, and a

Qualifications

  • Bachelor's or Master's degree in Engineering, Life Sciences, or Pharmaceutical Sciences.
  • 3–7 years of experience in medical devices or drug-device combinations.
  • Experience supporting technical documentation and regulatory submissions.
  • Knowledge of data integrity and document management principles.

Responsabilités

  • Maintain and track documentation plans aligned with milestones.
  • Coordinate collection and consolidation of technical documentation for Design Reviews.
  • Monitor readiness and raise delays or gaps to project teams.
  • Maintain trackers and dashboards to show deliverable status.
  • Support digitization and process improvement in device documentation.

Connaissances

Documentation coordination
Stakeholder management
Cross-functional collaboration
Attention to detail

Formation

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

Outils

Document management systems
Project tracking tools

Description du poste

UCB is seeking a Device Documentation Specialist to join the Devices, Artwork and Packaging team. You will coordinate development documentation and support design reviews and regulatory submissions.

Based on one of our BE or CH campuses, the role involves cross-functional collaboration with engineering, quality and regulatory to ensure data integrity and traceability. The ideal candidate has an engineering or life sciences background, 3–7 years in medical devices or pharmaceuticals, and a

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