Glaukos

Manager/Sr. Manager, Labeling Compliance

Glaukos • $107K — $179K *
Aliso Viejo, CA 92656In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • 5+ years for Manager or 8+ years for Senior Manager in medical device/pharmaceutical industry
  • Experience in developing and maintaining regulated product labeling
  • Strong understanding of global labeling standards and regulatory requirements
  • Excellent technical writing and communication skills
  • Ability to manage multiple projects and maintain attention to detail
  • Proficiency in Microsoft Office and Adobe Acrobat
  • Cross-functional collaboration experience with various teams.

Responsibilities

  • Develop and manage product labeling and related documentation
  • Ensure correctness of labeling content and specifications
  • Lead labeling change processes and documentation
  • Oversee external vendors for translation and printing services
  • Monitor global labeling regulations and drive improvements

Benefits

  • Collaborative work environment
  • Opportunity for career growth within a well-established company
  • Engagement with cross-functional teams across the organization
  • Onsite position in a central location in Aliso Viejo, CA
  • Focus on continuous improvement and professional development initiatives.
Full Job Description
Job Description

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

About Glaukos

Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent, its first MIGS device, in the United States in 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. The company's second-generation MIGS device, the iStent inject, was approved by the FDA in June 2018. Glaukos is also developing a pipeline of innovative technologies in corneal health, including the recently acquired Microline surgical platform, as well as novel drug delivery technologies.
Learn more about Glaukos
Size
727 employees
Market Cap
$1.9 billion
Industry
Healthcare
Net Income
-$120.3 million
Founded
1998
5 Year Trend
+20.8%
Revenue
$224.9 million
NASDAQ
GKOS
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Glaukos

More Pharmaceuticals & Biotech Jobs

Find similar Manager/Sr. Manager, Labeling Compliance jobs:

NationwideAliso Viejo, CA