Labeling Compliance Specialist

Company: Disability Solutions
Location: Danvers
Posted on: November 1, 2024

Job Description:

Abiomed is recruiting for a Labeling Compliance Specialist to join our team located in Danvers, MA.\rAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.\rI Am Abiomed - I Am Heart Recovery - Patients First!\rPrincipal Duties and Responsibilities\r

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• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures related to product labeling and instructions for use (IFU)
• Responsible for completion of the Label Assessment, including but not limited to redline of artwork and file creation translation management.
• Point person for New Product Development/LifeCycle teams in executing labeling strategies, project plans and executing project plans in support of label and IFU development for new product launches and lifecycle revisions.
• Responsible for leading collaboration for collecting requirements, alignment on label strategy and label content with Regulatory, Clinical, Quality, R&D, PM Lifecycle, as required.
• Accountable/responsible for working with labeling execution planning to align label development project plans with the project team schedules, escalating to resolve capacity constraints through prioritization, augmenting capacity or relieving project timing as aligned with project team and business units.
• Accountable for executing Design Control documentation and execution for label development.
• Govern the Intake Process for new labeling projects to ensure adequate resourcing and priority
• Manage cadence for Lifecycle changes to bring into labeling across the portfolio into compliance
• Lead the Labeling Program Management in support of larger scale complexity projects: develop timelines and identify risks
• Govern the Intake Process for new labeling projects to ensure adequate resourcing and priority
• Responsible for leading collaboration for collecting requirements, alignment on label strategy and label content with Regulatory, Clinical, Quality, R&D, PM Lifecycle as required.\r\r

Keywords: Disability Solutions, Newton , Labeling Compliance Specialist, Other , Danvers, Massachusetts