Labeling Specialist II
Glaukos Corporation, San Clemente, CA, United States
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 audit‑ready 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 in‑house printed labels (e.g., NiceLabel)
Provide cross‑functional guidance on labeling standards and formatting
Troubleshoot labeling issues and elevate discrepancies as needed
Ensure labeling documentation remains audit‑ready 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
#J-18808-Ljbffr
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 in‑house printed labels (e.g., NiceLabel)
Provide cross‑functional guidance on labeling standards and formatting
Troubleshoot labeling issues and elevate discrepancies as needed
Ensure labeling documentation remains audit‑ready 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
#J-18808-Ljbffr