Regulatory Labeling Associate

Integra Lifesciences Holdings Corporation • Princeton, NJ

388d

About The Position

The Regulatory Labeling Associate at Integra LifeSciences plays a crucial role in the execution and implementation of medical device labeling, ensuring compliance with internal standards and external regulatory requirements. This position involves collaborating with cross-functional teams to define project requirements, develop labeling content, and manage timelines for new product launches and updates. The associate will also be responsible for maintaining project tracking tools and ensuring adherence to labeling project timelines.

Requirements

• Bachelor's degree or higher is preferred.
• 1-2 years of experience in product labeling required.
• Functional operations of artwork and printing software execution.
• Functional understanding of label printer operations.
• Experience in product lifecycle management systems preferred.
• Strong organizational and project management skills.
• Aptitude for learning new software and systems.
• Ability to collaborate well with cross-functional business partners.
• Ability to acknowledge issues and work quickly to identify solutions.
• Knowledge/background in artwork creation and management for print production is a plus.
• Excellent writing and communication skills.
• Familiarity with change management systems.
• Knowledge of core Microsoft Office software including Word, PowerPoint, Excel, Team/SharePoint.

Nice To Haves

• Knowledge/background in artwork creation and management for print production.

Responsibilities

• Assist with the execution and implementation of medical device labeling.
• Collaborate with cross-functional teams including Marketing, Regulatory, Quality Assurance, R&D, and Global Operations.
• Develop, review, approve, and execute label development strategies and timelines.
• Coordinate and consolidate labeling content changes from cross-functional partners.
• Finalize label redlines and execute artwork updates through the workflow management system.
• Create and maintain labeling project tracking tools and dashboards.
• Support label content translation and verification process.
• Monitor and evaluate potential risk scenarios and lead resolution activities.
• Develop knowledge of labeling requirements and create compliant labeling across product portfolios.
• Attend project meetings and collaborate with the associated Labeling Specialist.

What This Job Offers

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