Manager/Sr. Manager, Labeling Compliance

Glaukos Corporation; San Clemente (CA); Presencial; USD 107.000 - 179.000; Jornada completa

Descripción de la vacante

Glaukos Corporation in Aliso Viejo, California, is seeking a Manager / Senior Manager, Labeling Compliance to oversee the development, control, and approval of product labeling and related documentation such as IFUs, manuals, and artwork.

You will lead the labeling change process, manage translations and labeling vendors, and ensure content accuracy, regulatory compliance, and alignment with global standards. Salary range is $107,000 to $179,200 annually, onsite.

Formación

• Experience with regulated product labeling and documentation.
• Knowledge of global labeling standards and regulatory requirements.
• Strong technical writing and attention to detail.

Responsabilidades

• Own development, control, maintenance, and approval of product labeling and related documents.
• Ensure labeling content and artwork are compliant and current.
• Lead labeling change processes and reviews.
• Manage translations, printing, and labeling vendors.
• Monitor labeling regulations and drive process improvements.

Conocimientos

Labeling management

Regulatory compliance

Vendor management

Technical writing

Cross-functional collaboration

Herramientas

Microsoft Office

Adobe Acrobat

Descripción del empleo

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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