Quality System Specialist- Labeling

MicroAire Surgical Instruments; Charlottesville (VA); On-site; USD 55,000 - 85,000; Full time

Job summary

MicroAire Surgical Instruments LLC is seeking a Labeling Specialist to manage the development, maintenance and controlled implementation of medical device product and packaging labeling aligned with regulatory compliance, new product development and production needs.

The role serves as the primary technical resource for labeling processes and systems, coordinating changes across functions and leading improvements for accuracy, compliance, and efficiency.

Qualifications

• Experience with medical device labeling requirements and regulatory standards.
• Ability to coordinate labeling changes across functions and systems.
• Familiarity with regulatory databases and product registrations.

Responsibilities

• Develops, revises, and verifies product packaging labeling according to approved product information and regulatory requirements, including 21 CFR Part 801, UDI, EU MDR, ISO 15223-1.
• Manages labeling activities with cross-functional teams and drives improvements for accuracy and compliance.
• Supports regulatory database maintenance, product registration, and related regulatory affairs activities as prioritized by the Quality Systems Manager.

Skills

Regulatory labeling

Cross-functional teamwork

Documentation

Attention to detail

Job description

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)