Labeling Specialist, Global Supply Chain
Core
Manage labeling change requests, design requirements, and translation workflows for medical device products to ensure compliance and patient safety.
Role type
Senior IC labeling specialist (medical device)
Builds
IFUs, Labels, and Implant Cards for cardiovascular devices
Domain
Medical device / Regulatory compliance
Required skills
labeling change management, translation project coordination, regulatory compliance, process improvement, risk evaluation, CAPA management, project management, documentation development, cross-functional collaboration
Preferred skills
MS Office Suite, leadership and influence, change management, problem-solving, organizational skills, analytical thinking, strict attention to detail
Technologies
MS Office Suite
Responsibilities
Define labeling design requirements and establish agreement on content and format for labeling change packages; review workflow expectations and milestones to ensure alignment with business strategy; identify, evaluate, and execute labeling change request tasks; partner with vendors on translation projects and manage translation workflows; lead sections of process improvement projects and revise procedures; support resolution of SCARs, NCRs, non-conformances, and CAPAs; develop and maintain timetables for labeling content creation and revisions; provide training and guidance to team members on labeling processes.
Seniority
Mid-level, hands-on IC