Labeling Compliance Manager – Medical Devices

Glaukos Corporation; Aliso Viejo (CA); On-site; USD 107,000 - 179,000; Full time

Job summary

Glaukos Corporation in Aliso Viejo, CA is seeking a Manager / Senior Manager, Labeling Compliance to lead the development, control, and approval of product labeling including IFUs, manuals, labels, artwork, and related documents.

You will ensure content accuracy, drive the change process, manage external vendors for translations and printing, monitor global regulations, and continually improve labeling processes and systems.

Qualifications

• Experience with labeling compliance in medical devices or pharmaceuticals.
• Experience developing and maintaining regulated product labeling and related documentation.
• Strong knowledge of global labeling standards and regulatory requirements.
• Excellent technical writing and documentation skills.
• Ability to manage multiple projects and stakeholders with attention to detail.

Responsibilities

• Own development, control, maintenance, and approval of product labeling and related documentation (IFUs, manuals, labels, artwork).
• Ensure labeling content, drawings, specifications, and artwork are accurate and compliant within quality systems.
• Lead labeling change process including ECO/DCC, reviews, approvals and implementation.
• Manage external vendors for translations, printing, and labeling services with version control and quality standards.
• Monitor global labeling regulations and drive continuous improvement of labeling processes and tools.

Skills

Labeling compliance

Regulatory documentation

Technical writing

Cross-functional leadership

Project management

Tools

Word

Excel

PowerPoint

Adobe Acrobat

Job description

Glaukos Corporation in Aliso Viejo, CA is seeking a Manager / Senior Manager, Labeling Compliance to lead the development, control, and approval of product labeling including IFUs, manuals, labels, artwork, and related documents.

You will ensure content accuracy, drive the change process, manage external vendors for translations and printing, monitor global regulations, and continually improve labeling processes and systems.