About this role
Position Overview:
Responsible for the design, development, maintenance, and revision of product labeling and packaging artwork for both vendor-supplied and in-house printed materials. This position specializes in detail-oriented graphic design for final labeling and packaging artwork, ensuring all labels, Instructions for Use (IFUs), and packaging artwork are accurate, compliant, visually effective, and production-ready. Supports multiple global manufacturing sites.
Responsibilities:
• Labeling & Artwork Development
• Design, develop, update, and maintain final product labels, carton artwork, inserts, Instructions for Use (IFUs), implant registration cards, patient record cards, and other labeling materials.
• Coordinate with Regulatory Affairs to ensure compliance with applicable regulatory standards including FDA, ISO, GHS, GS1, and market-specific requirements.
• Interpret and accurately incorporate regulatory content, warnings, symbols, barcodes, UDI requirements, serialization, and multilingual text into packaging and labeling layouts.
• Ensure proper use of typography, color standards, die-lines, bleeds, print specifications, and brand standards while maintaining visual clarity and consistency across global markets.
• Labeling & Artwork Support
• Coordinate with Regulatory Affairs, Quality Assurance, Quality Engineering, Operations, Marketing, and Sustaining Engineering to ensure all labeling and packaging materials are properly defined, integrated, verified, validated, and approved.
• Manage artwork revisions resulting from regulatory changes, formulation updates, market expansions, and product enhancements.
• Ensure packaging artwork and labeling comply with regulatory, customer, specification, and quality requirements.
• Documentation & Change Management
• Prepare and manage print-ready files through approval workflows, including version control, change management, and release processes.
• Maintain organized artwork archives, documentation, and electronic records to support audits, inspections, and global product lifecycle activities.
• Perform detailed quality checks to ensure labeling and packaging artwork accuracy, consistency, and compliance prior to release.
• Cross-Functional & Vendor Coordination
• Coordinate translation activities and integrate multilingual content into product labeling and packaging.
• Collaborate with external vendors, including translation services, printing suppliers, and packaging subcontractors.
• Support updates and validation of electronic labeling information and related digital content.
• Provide technical expertise and disseminate knowledge regarding labeling, packaging technologies, manufacturing systems, and regulatory requirements across the organization.
Qualifications:
• Bachelor's degree in graphic design, Visual Communication, Engineering, or related field; equivalent experience may be considered.
• Minimum of 3 years of experience in labeling or graphic design within a regulated industry such as medical devices or pharmaceuticals.
• Advanced proficiency in Adobe Creative Suite, including Illustrator, InDesign, and Photoshop.
• Experience with artwork management systems, PLM, DAM, labeling software (particularly enLabel), and document control systems preferred.
• Knowledge of FDA, ISO, UDI, barcoding, serialization, and multilingual labeling.
• Experience supporting global product launches and managing labeling changes across multiple markets preferred.
Other Factors of Job Performance
• Exceptional attention to detail with strong analytical and problem-solving abilities.
• Strong project management, organization, and version control skills.
• Excellent verbal and written communication skills with the ability to communicate technical and regulatory information effectively.
• Ability to work effectively in fast-paced, highly regulated environments while adapting to changing business and regulatory requirements.
• Demonstrates professionalism, initiative, reliability, discretion, and strong interpersonal skills.