Proofreader Global Labeling

About This Role

Proofreading global labeling and packaging graphics for critical medical devices is the core of this role, ensuring 100% accuracy, consistency, and regulatory compliance. The position involves reading, analyzing, and comparing original copy against formatted graphic proofs to detect and mark grammatical, typographical, compositional, or localization errors. This role suits a detail-oriented professional who can provide clear, actionable feedback to Graphic Designers for artwork corrections, ensuring all deliverables align with brand guidelines, global regulatory standards, and corporate compliance mandates.

Responsibilities

• Verify complete documentation packages for artwork releases, ensuring all supporting design inputs, source files, and translation databases are aligned
• Strictly adhere to Good Documentation Practices (GDP) and maintain robust, audit-ready documentation records within the Quality Management System (QMS)
• Confer with document originators, labeling engineers, regulatory affairs, and engineering liaison personnel to resolve packaging discrepancies and compile required changes
• Proofread computer-generated product labeling, regulatory symbols (ISO 15223), global variable data, barcodes, and clinical/investigational labels to ensure zero defects
• Support the continuous update of global labeling components to comply with changing international regulations (such as FDA 21 CFR Part 820 and EU MDR)
• Lead the proofreading phase within established project timelines to guarantee zero discrepancies between master source documents and final formatted design proofs
• Support labeling change execution by authoring, submitting, and routing formal change packages, including Document Change Requests (DCR) and Change Requests (CR) through PLM/document control systems
• Perform other labeling compliance and quality assurance duties as assigned to support global supply chain readiness

Requirements

• 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
• Experience working within an in-house corporate labeling department or a regulated packaging production agency is highly 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 is highly desirable
• Understanding of Document Control systems and PLM software (e.g., Windchill, Agile, or SAP) is a plus
• Exemplary visual acuity and cognitive stamina for managing repetitive, high-detail comparative analysis