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Manager/Sr. Manager, Labeling Compliance

Glaukos Corporation · glaukos.com
Aliso ViejoOn-siteLead / Manager8+ yrs
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The job in short

Manage product labeling compliance and labeling change process for medical devices.

ExcelClinicalCompliance

Details

Found
36 d ago · posted 2026-09-09
Location
Aliso Viejo, CA

Full description

Manager / Senior Manager, Labeling Compliance Location: Aliso Viejo, CA How You’ll Contribute The Manager/ Sr. Manager is responsible for managing activities which ensure Glaukos product labeling meets established standards of quality, including process improvement and enhancement. What You’ll Do • Own the development, control, maintenance, and approval of product labeling, including IFUs, manuals, labels, patient implant cards, artwork, and related documentation. • Ensure labeling content, drawings, specifications, and artwork remain accurate, compliant, and current within document control and quality systems. • Lead the labeling change process, including ECO/DCC activities, Labeling Committee reviews, documentation, approvals, and implementation. • Manage external vendors for translations, printing, and labeling services, ensuring qualification, version control, and quality standards are maintained. • Monitor global labeling regulations and industry requirements; drive continuous improvement of labeling processes, tools, systems, and compliance practices. How You’ll Get There • Manager: 5+ years; Senior Manager: 8+ years of medical device and/or pharmaceutical industry experience, including leadership responsibility. • Experience developing, reviewing, and maintaining regulated product labeling and associated documentation. • Strong knowledge of global labeling standards, regulatory requirements, and document control processes. • Excellent technical writing, documentation, and communication skills. • Strong attention to detail and ability to manage multiple projects and stakeholders. • Experience with Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat. • Ability to read, write, and communicate effectively in English. • Experience collaborating cross-functionally with Regulatory Affairs, Quality, R&D, Clinical, and Commercial teams. • Working knowledge of QMSR preferred. • This role is based onsite in Aliso Viejo, CA. • This position may be filled at either the Manager or Senior Manager level, depending on the selected candidate's qualifications, experience and demonstrated leadership capabilities. • Salary Range 107,000. - 179,200.00 #GKOSUS

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