Spec RA GSO
Core
Review and document labeling for medical devices, drugs, cosmetics, and commodities to ensure compliance with internal procedures and federal regulations.
Role type
Regulatory Affairs Specialist (Labeling)
Builds
Medline branded labels and regulatory documentation
Domain
Medical device and pharmaceutical regulatory compliance
Required skills
Regulatory compliance knowledge, label design review, CAPA management, supplier communication, risk assessment, data collection
Preferred skills
FDA/CE-marked device experience, UDI data management, new hire training
Technologies
GUDID system, Medline internal systems
Responsibilities
Review Medline branded labels for compliance with federal laws and internal procedures; Coordinate with product managers, QA, and designers on labeling conflicts; Conduct investigations and corrective actions (CAPA) for labeling issues; Communicate with suppliers for labeling implementation; Collect and maintain regulatory data (UDI, FDA registration); Perform adverse event analysis for CE-marked devices.