Medical Device Project Manager

Overview

Role : Project Manager - Labeling

Location : Irving, TX

Contract type : Long Term Contract

This role will be expected to lead label design change project for conformance to the ISO14607 : 2024 standard update. This role will be based out of Irving, TX and be responsible for leading and executing the Label Change scope for the Texas site.

Responsibilities

• Accountable for new product and lifecycle labeling project portfolio management. Responsible for lifecycle label change requests and accountable for end-to-end execution of labeling changes in support of artwork only changes. Support the labeling changes that drive business unit objectives and strategies, regulatory and compliance requirement changes and supply chain strategies.
• Point person for business units in developing labeling strategies, project plans and executing project plans. Engaged with business units directly and represents labeling function.
• Lead the New Product and Lifecycle Labeling Project Portfolio Review Process which includes a cadence of obtaining project requests, participating in Business Unit Lifecycle team governance, and leading cross-functional team to review the projects' business case, conduct risk analysis and develop recommendations for approval, priority and project change governance.
• Partner with PM Lifecycle Product Manager, Quality, Regulatory, Marketing associates for prioritization and execution strategies.
• Represent Lifecycle Labeling Portfolio recommendations to appropriate governance bodies for approval of recommendations. Ensure stakeholders understand outputs of all decisions and track project status.

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