Regulatory Labeling Associate - Design

Integra Lifesciences Holdings Corporation • Princeton, NJ

432d

About The Position

The Regulatory Labeling Associate - Design at Integra LifeSciences is responsible for the creation, review, approval, and maintenance of finished goods labeling artwork and templates. This role plays a crucial part in ensuring compliance with various regulatory requirements, including FDA, MDR, and ISO, while effectively managing the end-to-end label implementation process. The position requires collaboration with team members and project teams to execute labeling projects efficiently.

Requirements

• Bachelor's degree or higher is preferred.
• 1-2+ years of experience in production labeling required.
• Functional operations of artwork and printing software execution.
• Functional understanding of label printer operations.
• Experience in production lifecycle management systems preferred.
• Excellent attention to detail and organizational skills, with a strong emphasis on data entry.
• Basic project management skills.
• Aptitude for learning new software and systems.
• Ability to acknowledge issues or problems and work quickly to identify solutions.
• Knowledge of core Microsoft Office software including Word, PowerPoint, and Excel.
• Capable of multi-tasking and problem solving.
• Demonstrates proficient writing and communication skills.
• Familiarity with change management, including data uploads, data identification, data formatting and data verification procedures.

Responsibilities

• Assist in the design, development, and approval of product labeling, working closely with the Labeling Specialists.
• Coordinate the execution of product label artwork utilizing Integra's validated artwork management system (Kallik).
• Create and maintain labeling project tracking tools and dashboards to monitor all labeling change deliverables across assigned projects and sites.
• Collaborate and communicate with direct team members and project teams on all project execution.
• Assist the Senior Labeling Associate in integrating and implementing Integra's electronic labeling artwork management system across manufacturing sites.
• Coordinate and support labeling production implementation processes with manufacturing sites and vendors.
• Execute on-demand label print proofs, barcode grading/verification.
• Troubleshoot and resolve hardware and software errors in print production.
• Maintain Zebra printer and label stock inventory.
• Perform data entry and verification in print production software for artwork creation and related tasks.
• Support data gathering to the Labeling Documentation Specialist on labeling requests.
• Perform all other related duties as directed by manager.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Management of Companies and Enterprises
• Education Level: Bachelor's degree