Manager/Sr. Manager, Labeling Compliance

Manager / Senior Manager, Labeling ComplianceLocation: Aliso Viejo, CAHow 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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