Regulatory Labeling Specialist - 27661

Job Description

Job Description

Regulatory Labeling Specialist

Employment Type: 12-Month+ Contract

Shift: 1st Shift | Monday–Friday, 8:00 AM–5:00 PM

We are seeking a detail-oriented Regulatory Labeling Specialist to support labeling development, documentation, and regulatory compliance for a global medical device manufacturer.

This role focuses on creating and updating product labeling, maintaining accurate documentation, supporting labeling verification, and ensuring compliance with GMP and Quality System Regulation (QSR) requirements. The ideal candidate has strong attention to detail, technical documentation skills, and the ability to collaborate across multiple departments.

Key Responsibilities

• Create and update product labeling using established templates, style guides, and labeling software.
• Maintain labeling documentation, including drawings, change orders, specifications, and technical records.
• Use GLS/Prisym, Adobe products, Microsoft Office, and other labeling tools.
• Operate Zebra label printers, barcode graders, and related equipment.
• Troubleshoot label printing issues and support labeling verification activities.
• Coordinate with Operations to implement new or revised labeling in production.
• Review labeling changes for accuracy, consistency, and regulatory compliance.
• Maintain documentation within PLM and other document control systems.
• Update SOPs, work instructions, technical literature, forms, and templates.
• Support project timelines, labeling reviews, and approval processes.
• Investigate documentation discrepancies and support corrective actions.
• Collaborate with Regulatory Affairs, Quality, R&D, Packaging Engineering, Manufacturing, Legal, and Product Marketing.
• Support continuous improvement initiatives and maintain compliance with GMP and QSR standards.

What We're Looking For

• Strong attention to detail and accuracy in technical documentation.
• Ability to manage multiple labeling projects and meet deadlines.
• Proficiency with Microsoft Office and familiarity with Adobe products.
• Ability to work with cross-functional teams in a regulated manufacturing environment.
• Strong organizational, communication, and problem-solving skills.
• Understanding of document control, quality systems, and regulatory compliance.

Preferred Experience:

• Medical device manufacturing or another regulated industry.
• Product labeling development, verification, or regulatory documentation.
• GLS/Prisym or similar labeling software.
• Zebra printers, barcode verification, or labeling equipment.
• PLM systems, GMP, QSR, and quality documentation processes.

Apply Today!

If you have experience in regulatory labeling, technical documentation, or medical device quality systems, we encourage you to apply for this Regulatory Labeling Specialist opportunity.