Labeling Specialist II

GLAUKOS - LABELING SPECIALIST II (San Clemente, CA)

The Labeling Specialist is responsible for creating, updating, and managing product labeling for medical device and pharmaceutical products with moderate independence. This role supports labeling development from initial artwork through final approval, ensuring compliance with regulatory standards and internal procedures. The Labeling Specialist II partners with Regulatory, Quality, R&D, Operations, and external vendors to ensure accurate, consistent, and auditready labeling. This role requires strong attention to detail, familiarity with labeling systems, and the ability to manage multiple labeling projects simultaneously.

What Will You Do

• Create, update, and maintain labeling content, artwork, and drawings following Glaukos procedures
• Prepare labeling deliverables, ensuring accuracy, consistency, and regulatory compliance
• Manage ECOs, DCC changes, and related workflows with limited oversight
• Coordinate with vendors for translations, graphics support, and printed label production
• Ensure correct application of symbols, regulatory marks, and product identifiers
• Maintain document control accuracy across systems (Oracle, Veeva, TrackWise)
• Support creation and maintenance of inhouse printed labels (e.g., NiceLabel)
• Provide crossfunctional guidance on labeling standards and formatting
• Troubleshoot labeling issues and escalate discrepancies as needed
• Ensure labeling documentation remains auditready and compliant with quality system requirements
• Support process improvements and labeling standardization initiatives
• Perform other duties as assigned

How Will You Get Here

• 2-5 years of experience in labeling, document control, regulatory, or a related medical device/pharma field
• Bachelor's degree preferred
• Strong understanding of labeling processes, document control, and version management
• Ability to read and understand drawings, artwork files, and regulatory symbols
• Proficiency in Microsoft Office; exposure to labeling tools (NiceLabel, Adobe, etc.) preferred
• Strong written/verbal communication skills
• Ability to manage multiple projects with minimal supervision
• Attention to detail, accuracy, and documentation quality

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