Lead Labelling Specialist
Core
Lead technical authority for complex medical device labelling challenges, solving ambiguous regulatory and product lifecycle issues while shaping global labelling systems and governance.
Role type
Senior IC Lead Labelling Specialist (Regulatory & Systems)
Builds
End-to-end labelling system architecture, workflows, decision points, interfaces, and escalation pathways across the product lifecycle.
Domain
Medical Devices / Regulatory Compliance / Technical Operations
Required skills
Medical device labelling regulations, risk-based judgement, process design, structured-content governance, traceability, change control, audit readiness, stakeholder management, technical leadership, system architecture, continuous improvement
Preferred skills
Healthcare industry experience, end-to-end process architecture, ELS/CCMS systems, global market navigation, AI/automation in regulated workflows, advanced degree
Technologies
ELS/CCMS, structured-content systems, AI-enabled content tools
Responsibilities
Solve complex, ambiguous, high-impact labelling challenges; Shape end-to-end labelling system architecture; Provide technical leadership on regulatory interpretation; Lead development of improved processes and tooling; Act as senior technical escalation point; Align business across regulatory, quality, engineering, and UX; Strengthen governance for requirements and traceability; Provide technical leadership for localization and translation; Drive continuous improvement initiatives; Mentor and develop team members; Communicate complex technical information to senior stakeholders
Seniority
Senior, hands-on IC with leadership influence
