Medical Device Labeling Specialist — Regulatory & Quality

Marmon Holdings; Charlottesville (VA); On-site; USD 85,000 - 110,000; Full time

Job summary

MicroAire Surgical Instruments LLC is seeking a Labeling Specialist to lead development, maintenance and controlled implementation of medical device labeling across product lines, ensuring regulatory compliance from design through production.

You will partner with Regulatory Affairs, Quality, Supply Chain and Manufacturing to coordinate labeling changes, document control, ERP integration and system validation, supporting GUDID/EUDAMED as needed.

Qualifications

• Bachelor's degree in science or engineering required.
• 3–5 years of medical device labeling experience.
• Knowledge of FDA labeling requirements and ISO 13485.

Responsibilities

• Manage labeling activities and coordinate reviews across functions.
• Develop and verify product packaging labeling per regulations.
• Maintain labeling software and ERP interface coordination.
• Support regulatory submissions and product registrations.
• Investigate labeling issues and implement corrective actions.

Skills

Attention to detail

Regulatory compliance

Project management

Documentation

Communication skills

MS Office

Education

Bachelor's Degree in science or engineering

Tools

Labeling software

ERP interfaces

Graphic design software

Job description

MicroAire Surgical Instruments LLC is seeking a Labeling Specialist to lead development, maintenance and controlled implementation of medical device labeling across product lines, ensuring regulatory compliance from design through production.

You will partner with Regulatory Affairs, Quality, Supply Chain and Manufacturing to coordinate labeling changes, document control, ERP integration and system validation, supporting GUDID/EUDAMED as needed.