Labeling Specialist

Position Summary

Support the creation, maintenance, and management of medical device labeling using BarTender software. Ensure labels meet regulatory, quality, and packaging requirements while partnering with cross-functional teams in a regulated medical device environment.

Key Responsibilities

• Design, update, and maintain medical device labels using BarTender.
• Manage label changes through the full lifecycle, including creation, review, approval, and retirement.
• Develop labeling content and associated documentation.
• Partner with Packaging, Regulatory, Quality, and Manufacturing teams to ensure labeling compliance and accuracy.
• Manage labeling records and approvals within PLM/QMS systems.
• Troubleshoot labeling issues and support audits, inspections, and continuous improvement initiatives.
• Ensure compliance with FDA, ISO 13485, and other applicable regulations.

Required Qualifications

• 4+ years of medical device labeling experience.
• Hands-on experience with BarTender labeling software.
• Knowledge of ISO 13485, 21 CFR 820, and medical device labeling requirements.
• Experience with technical documentation, label lifecycle management, and change control processes.
• Familiarity with PLM and QMS systems.
• Strong attention to detail, technical writing, and organizational skills.
• Ability to work independently and collaborate across functions.

Preferred Qualifications

• Experience with Agile PLM, Windchill, or similar systems.
• Knowledge of UDI, FDA labeling regulations, and EU MDR requirements.
• Experience in document control and fast-paced medical device environments.
• Strong cross-functional communication and project management skills.