Senior Regulatory Labeling Specialist
Core
Authoring and maintaining Instructions for Use (IFU) and product labeling, and reviewing marketing materials for regulatory compliance in the medical device industry.
Role type
Senior Regulatory Labeling Specialist
Builds
Global regulatory documentation and compliant marketing assets for AI-driven cardiac care products
Domain
Medical Devices / Cardiovascular Technology / Regulatory Affairs
Required skills
Technical writing, Regulatory compliance (FDA, EU MDR), Labeling authoring, Cross-functional collaboration, Document version control, Localization management, IT systems proficiency
Preferred skills
XML, Structured authoring tools, Translation management systems, UDI registration, MadCap Flare, Command-line scripting
Technologies
MasterControl, Veeva, Arena, SharePoint, TrackWise, eCTD, GUDID, EUDAMED
Responsibilities
Lead creation and maintenance of IFUs and technical labeling; Review marketing and promotional materials for regulatory claims; Manage document version control and localization workflows; Utilize EDMS and PLM software for asset management; Assist with regulatory submissions and audits.
Seniority
Senior, hands-on IC