Product Information / Labeling Subject Matter Expert (SME) - Medical Devices
Core
Lead global product labeling, Instructions for Use (IFU), packaging, and regulatory documentation for medical devices to ensure compliance and accuracy across markets.
Role type
Senior Subject Matter Expert (SME) in Medical Device Product Information & Labeling
Builds
Regulated product documentation, labeling content, and UDI data for medical device manufacturers
Domain
Healthcare / Life Sciences / Medical Devices
Required skills
Global medical device labeling regulations (FDA 21 CFR Part 801, EU MDR), UDI/GUDID/EUDAMED, Quality Management Systems (QMS), document/change control, risk management (ISO 14971), Enterprise Labeling Management Systems (ELMS), PLM platforms, translation/localization coordination
Preferred skills
Regulatory Affairs Certification (RAC), Adobe InDesign/Illustrator, Human Factors/Usability Engineering knowledge
Technologies
Loftware, BarTender, PRISYM ID, Windchill, Arena, Agile PLM, GUDID, EUDAMED
Responsibilities
Define global labeling strategies for new product introductions and lifecycle changes; conduct labeling gap assessments; ensure compliance with FDA, EU MDR, and ISO standards; manage UDI creation and submissions; lead creation, review, and approval of controlled labeling content; coordinate translation and localization; partner with Regulatory Affairs, Quality, and Manufacturing teams; support root cause analysis and CAPA for labeling issues
Seniority
Senior, hands-on IC with strategic oversight