Spec RA GSO
Core
Review and document labeling for commodity, medical device, drug, and cosmetic products to ensure compliance with internal procedures and federal regulations.
Role type
Regulatory Affairs Specialist (Labeling)
Builds
Medline branded labels and regulatory documentation
Domain
Medical devices and pharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory compliance knowledge, label design review, CAPA management, supplier communication, risk assessment, data collection
Preferred skills
Experience with UDI data, FDA product registration, CE-marked device adverse event analysis
Technologies
GUDID system, Medline internal systems
Responsibilities
Review Medline branded labels against PM requests and mock-ups; Coordinate with PMs, QA, designers, and RA colleagues on labeling conflicts; Archive approved labels per internal procedures; Communicate with suppliers for labeling implementation; Conduct investigations and corrective actions on labeling problems (CAPA); Lead supplier problem solving and improvement (SCAR); Participate in project plan setup and implementation for labeling projects; Provide professional advice during risk assessment; Collect and maintain regulatory data (UDI, FDA registration); Search and analyze adverse events for CE-marked devices; Initiate certificates of conformity and Declaration of Conformity.
Seniority
Individual Contributor
