Manager/Sr. Manager, Labeling Compliance

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 effective 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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