Senior Labelling Specialist
Core
Develop and maintain medical device labelling (user guides, clinical guides, labels) across the product lifecycle, translating regulatory and product inputs into clear, compliant messaging.
Role type
Senior Labelling Specialist (Medical Devices)
Builds
User guides, clinical guides, and product labels for medical devices
Domain
Medical Devices / Healthcare / Regulatory Compliance
Required skills
Regulatory interpretation, structured content management, change-impact assessment, quality system principles, risk management, technical writing, cross-functional collaboration, process improvement, system troubleshooting, AI/automation evaluation
Preferred skills
Medical device industry experience, regression testing, structured authoring platforms, global market labelling knowledge, team coaching, AI/automation in content workflows
Technologies
ELS/CCMS, structured content systems, AI/automation tools
Responsibilities
Translate requirements into labelling outcomes; Assess change impact; Manage controlled labelling content; Strengthen governance; Support quality and verification; Manage issues and dependencies; Support global labelling; Improve how we work; Support labelling systems; Push the edge with AI/automation; Build team capability; Communicate effectively
Seniority
Senior, hands-on IC with mentorship responsibilities