Quality System Specialist- Labeling

MicroAire Surgical Instruments LLC As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best. The Labeling Specialist manages the development, maintenance and controlled implementation of medical device product and packaging labeling support to regulatory compliance, new product development and production requirements. Serves as the primary technical resource for labeling processes and systems, coordinates labeling changes across functions, and leads improvements that strengthen accuracy, compliance, and operational efficiency. Supports regulatory database maintenance, product registration, and other Regulatory Affairs activities according to priorities established by the Quality Systems Manager. Quality/Regulatory Reports to: Quality Systems Manager Exempt Essential Duties and Responsibilities Manages assigned medical device labeling activities and works with cross functional teams Requirements Develops, revises, and verifies product packaging labeling according with approved product information, applicable regulatory requirements, and internal procedures, including applicable requirements related to: 21 CFR Part 801 (Medical Device Labeling) UDI (Unique Device Identification) EU MDR (Medical Device Regulation) ISO 15223-1 (Medical Device Symbols) #J-18808-Ljbffr MicroAire Surgical Instruments