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, and traceable outcomes.
Role type
Senior Labelling Specialist (Medical Devices)
Builds
Medical device user documentation, clinical guides, and product labels
Domain
Medical Devices / Healthcare / Regulatory Compliance
Required skills
Regulatory interpretation, structured content management, change-impact assessment, risk-based approach, technical review leadership, global localization coordination, process improvement, team coaching
Preferred skills
Medical device industry experience, regression testing, structured authoring platforms, AI/automation in content workflows, multi-market labelling knowledge
Technologies
ELS/CCMS, legacy enterprise systems
Responsibilities
Translate regulatory and product requirements into controlled labelling outcomes; Lead or contribute to regression and change-impact assessments; Manage and maintain labelling content using structured-content principles; Ensure consistency, traceability, and audit readiness of labelling decisions; Lead technical reviews and verification activities; Coordinate with external partners for localization and translation; Identify and implement process improvements; Troubleshoot content management systems; Evaluate and support AI-enabled content approaches; Coach colleagues and build team capability.
Seniority
Senior, hands-on IC with mentorship responsibilities
