What are the responsibilities and job description for the Regulatory Labeling Associate position at Integra LifeSciences?
Changing lives. Building Careers.Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.The Labeling Associate will assist with the execution and implementation of medical device labeling, ensuring compliance with both internal corporate standards and external regulatory requirements. This role will be assisting the strategic and tactical labeling projects from the business to meet quality standards, timelines, company goals, regulatory compliance, and cost management / process efficiency objectives. The Labeling Associate will collaborate with cross-functional teams, including Marketing, Regulatory, Quality Assurance, R&D, and Global Operations, to define project requirements, artwork specifications, and verify content. Additionally, the role involves developing, reviewing, approving, and executing label development strategies and timelines to support new product launches and updates. Functional understanding of regional regulatory requirements is essential, ensuring compliance with FDA, MDR, ISO, and other global regulations.To perform this job successfully, an individual must be able to perform each essential dutysatisfactorily.The Labeling Associate will attend project meetings and collaborate with the associated Labeling Specialist for assignment and execution for related work and project activities in the Labeling Workstream.Work with core product teams assist to develop labeling content holistically for all levels / layers of labeling in multiple product families / portfolios.Coordinate and consolidate labeling content changes provided by cross-functional partners, finalize label redlines, and execute artwork updates through the workflow management system shared with the Graphics Team.Execute artwork labeling content approval process workflows in a validated approval system.Create and maintain labeling project tracking tools and dashboards to monitor all labeling change deliverables across project teams and sites for all impacted labeling components.Support label content translation and verification processMaintain and ensure adherence to labeling project timelines and deliverablesMonitor and evaluate potential risk scenarios and lead resolution activities to mitigate project timeline riskDevelop knowledge and understanding of labeling requirements and create compliant and harmonized finished good labeling across product portfoliosPerforms all other related duties as directed by manager.QUALIFICATIONSThe requirements listed below are representative of the knowledge, skill, and / or ability required for this position.Bachelor's degree or higher is preferred. 1-2 years of experience in product labeling requiredMust possess and demonstrate functional operations of artwork and printing software executionMust possess and demonstrate a functional understanding of label printer operationsExperience in product lifecycle management systems preferredStrong organizational and project management skillsAptitude for learning new software and systemsAbility to collaborate well with cross-functional business partners across a large matrix organizationAbility to acknowledge issues or problems and work quickly to identify solutions as both an individual contributor and team contributorKnowledge / background in artwork creation and management for print production and manufacturing is a plusDemonstrates excellent writing and communication skillsFamiliarity with change management systemsKnowledge of core Microsoft Office software including Word, PowerPoint, Excel, Team / SharePointIntegra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices : EEO Is the Law () | EOE including Disability / Protected Veterans ()Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA () . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.Integra - Employer Branding from Integra LifeSciences on Vimeo ()
