Regulatory Labeling Associate - Design

Integra Lifesciences Holdings Corporation-posted about 1 year ago
Full-time • Entry Level
Princeton, NJ
Management of Companies and Enterprises
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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.

  • 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.
  • 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.
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