Manager​/Sr. Manager, Labeling Compliance

Manager / Senior Manager, Labeling Compliance

Location:

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.

• 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.

• 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.
  
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