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

Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.

Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.

Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.

Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.

Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.

Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol "GKOS". Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.

Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

All offers of employment are contingent upon the successful completion of a background check, including successfully passing a drug screen, based on the position and local regulations.