Manager/Sr. Manager, Labeling Compliance

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

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

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