Quality System Specialist- Labeling
Core
Manages the development, maintenance, and controlled implementation of medical device product and packaging labeling to ensure regulatory compliance and support new product development.
Role type
Quality System Specialist (Medical Device Labeling)
Builds
Medical device product packaging and labeling systems compliant with FDA, EU MDR, and ISO standards
Domain
Medical Devices / Regulatory Affairs / Quality Systems
Required skills
Medical device labeling regulations (FDA 21 CFR 801, EU MDR, UDI, ISO 15223-1), Regulatory database management (GUDID, EUDAMED), Label design and printing systems, ERP system integration, Root cause analysis, Change control processes, Product registration, Cross-functional coordination
Preferred skills
Experience with sterile device or capital equipment labeling, Graphic design software, Advanced ERP interface administration
Technologies
GUDID, EUDAMED, ERP systems, Label design/printing software, Microsoft Office
Responsibilities
Develop and verify product packaging labeling per regulatory requirements; Coordinate labeling reviews, approvals, and implementation; Investigate labeling errors and implement corrective actions; Maintain regulatory databases and product registrations; Lead labeling process improvements and automation; Support Regulatory Affairs submissions and documentation requests
Seniority
Mid-level, hands-on IC