Device Documentation Lead
Hybrid · Braine-l'Alleud, Wallonia, Belgium
Job Summary
Lead and manage device and packaging documentation activities across development programs; define and implement documentation strategies to ensure consistency across programs; author, review, and approve technical and scientific documentation aligned with regulatory requirements; ensure documentation readiness for design reviews and regulatory submissions; coordinate documentation activities across cross-functional teams; identify gaps and risks in documentation and implement mitigation actions; ensure compliance with QA, GMP, and regulatory requirements including data integrity; develop and maintain procedures, guidance documents, and best practices; support continuous improvement and digital transformation of documentation processes.
Required Qualifications
- Master’s degree in a scientific or engineering discipline
- Extensive experience in drug–device 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 stakeholder-influencing skills in global, matrix organisations
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