Labeling Specialist II

Glaukos • San Clemente, CA

8d

About The Position

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.

Requirements

• 2–5 years of experience in labeling, document control, regulatory, or a related medical device/pharma field
• 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
• Strong written/verbal communication skills
• Ability to manage multiple projects with minimal supervision
• Attention to detail, accuracy, and documentation quality

Nice To Haves

• Bachelor’s degree preferred
• exposure to labeling tools (NiceLabel, Adobe, etc.) preferred

Responsibilities

• 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 escalate 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level