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 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