Global Labeling Proofreader for Medical Devices

Cardinal Health; Denver (CO); On-site; USD 37,000 - 48,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health seeks a Proofreader – Global Labeling to ensure 100% accuracy and regulatory compliance of labeling and packaging graphics for medical devices. You will compare typescript to proofs, verify ISO symbols, barcodes, and multi-language inserts, and collaborate with design and regulatory teams.

You will uphold GDP, maintain audit-ready records in QMS, and manage change packages through PLM systems, supporting global labeling updates and adherence to FDA/EU regulations.

Qualifications

• Bachelor’s degree in English, Technical Writing, Journalism, Life Sciences, or a related technical discipline preferred
• 2+ years of professional-level proofreading, preferably within a medical device, pharmaceutical, biotech, or highly regulated packaging environment preferred
• Agency context experience in in-house labeling dept. or regulated packaging production agency preferred
• Strong hands-on experience with Adobe Acrobat (markup tools), Microsoft Office Suite, and professional PDF comparison software
• Familiarity with automated text and pixel-verification proofreading software desirable

Responsibilities

• Artwork & Document Verification: Verifies complete documentation packages for artwork releases, ensuring all supporting design inputs, source files, and translation databases are aligned.
• Regulatory Compliance & GDP: Strictly adheres to GDP and maintains audit-ready documentation within the QMS.
• Cross-Functional Collaboration: Confers with originators, labeling engineers, regulatory affairs, and engineering liaison personnel to resolve packaging discrepancies and compile changes.
• Quality Proofreading: Proofreads labeling, regulatory symbols (ISO 15223), global variable data, barcodes, and clinical/investigational labels for zero defects.
• Regulatory Alignment Support: Supports updates to comply with changing international regulations (FDA 21 CFR Part 820 and EU MDR).
• Project Timeline & Quality Review: Leads proofreading within project timelines to guarantee zero discrepancies between master documents and proofs.
• Change Control Management: Assists labeling change execution by authoring, submitting, and routing Change Packages through PLM/document control systems.
• Operational Agility: Performs other labeling compliance and QA duties to support global supply chain readiness.

Skills

Proofreading

Attention to detail

Regulatory understanding

Communication

English proficiency

Education

Bachelor’s degree in English, Technical Writing, Journalism, Life Sciences, or related discipline

Tools

Adobe Acrobat

Microsoft Office

PDF comparison software

Job description

Cardinal Health seeks a Proofreader – Global Labeling to ensure 100% accuracy and regulatory compliance of labeling and packaging graphics for medical devices. You will compare typescript to proofs, verify ISO symbols, barcodes, and multi-language inserts, and collaborate with design and regulatory teams.

You will uphold GDP, maintain audit-ready records in QMS, and manage change packages through PLM systems, supporting global labeling updates and adherence to FDA/EU regulations.