Labeling Quality Systems Specialist

Marmon Holdings, Inc.; Charlottesville (VA); On-site; USD 70,000 - 95,000; Full time

Job summary

The Quality System Specialist- Labeling in Charlottesville, VA supports labeling of medical device products and packaging, ensuring compliance with FDA 21 CFR Part 801, EU MDR, ISO 13485, UDI, and related standards. You will manage labeling development, reviews, change control, and ERP integration.

You will collaborate with Regulatory Affairs, Quality, Engineering, and Manufacturing to implement improvements, verify labeling, and maintain GUDID/EUDAMED registrations.

Qualifications

• Bachelor's degree required in science/engineering or related field.
• 3–5 years’ experience in medical device labeling and controlled labeling changes.
• Good verbal and written communication skills with high attention to detail.
• Working knowledge of FDA labeling requirements, EU MDR, Health Canada, ISO 13485, and UDI.

Responsibilities

• Manage medical device labeling activities and coordination with cross-functional teams.
• Develop, revise, and verify product packaging labeling per approved information and regulatory requirements.
• Coordinate labeling reviews, approvals, and implementation through document/change control.
• Maintain regulatory databases and support product registrations (GUDID/EUDAMED).
• Support regulatory submissions and responses to information requests.

Skills

Regulatory knowledge

Attention to detail

Cross-functional collaboration

Project management

Communication

Education

Bachelor's degree in science/engineering

Tools

Labeling software

ERP interfaces

Regulatory databases (GUDID/EUDAMED)

Job description

The Quality System Specialist- Labeling in Charlottesville, VA supports labeling of medical device products and packaging, ensuring compliance with FDA 21 CFR Part 801, EU MDR, ISO 13485, UDI, and related standards. You will manage labeling development, reviews, change control, and ERP integration.

You will collaborate with Regulatory Affairs, Quality, Engineering, and Manufacturing to implement improvements, verify labeling, and maintain GUDID/EUDAMED registrations.