Job description

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.

Requirements

Must-haves

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
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.
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.
Knowledge of FDA, ISO, UDI, barcoding, serialization, and multilingual labeling.
Other Factors of Job Performance

Nice-to-haves

Experience with artwork management systems, PLM, DAM, labeling software (particularly enLabel), and document control systems preferred.
Experience supporting global product launches and managing labeling changes across multiple markets preferred.

Application prep

Use the role’s language and application details while tailoring your materials.

Platform: ukg
Effort: medium

Benefits

Benefits detected in the listing.

Vision