Labeling Specialist II at Glaukos Corporation

San Clemente, California, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Jun, 26

Salary

92000.0

Posted On

13 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Labeling, Document Control, Regulatory Compliance, Artwork Management, ECO Management, DCC Changes, Vendor Coordination, Labeling Systems, NiceLabel, Oracle, Veeva, TrackWise, Attention To Detail, Project Management, Technical Drawings, Regulatory Marks

Industry

Medical Equipment Manufacturing

Description

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 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 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 #GKOSUS

Responsibilities

The Labeling Specialist II is responsible for creating, updating, and managing product labeling for medical device and pharmaceutical products, supporting development from initial artwork through final approval while ensuring regulatory compliance. This role involves coordinating with cross-functional teams and external vendors to maintain accurate, consistent, and audit-ready labeling documentation.