EUMDR Labeling Leader

Employment Type

: Full-Time

Industry

: Information Technology



The EU MDR Labeling Leader is responsible for driving Integra's overall EU MDR labeling strategy and process improvements across all labeling sites. Collaborates with cross-functional partners and key stakeholders in Regulatory, Quality Assurance, Supply Chain, R&D and Global Operations to help define and develop enterprise level labeling strategies and execution plans for all MDR compliance requirements, including Labeling Updates, Patient Cards, and supply chain and labeling process improvements. The EU MDR Labeling Leader will work closely with cross functional partners in Quality Assurance, Global Operations, and Regulatory to develop labeling project plans aligned with program objectives, coordinates a cross functional team to design and prepare compliance strategies and process improvements, ensures progress towards EU MDR compliance timelines, and leads change management as new labeling strategies are introduced. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Primary responsibilities are to: Lead a cross functional team to develop specific strategies and create a project plan for EU MDR labeling compliance. Develop enterprise strategies for new labeling requirements, including patient cards, importer labeling, and eIFUs. Identify tools and resources required to centralize and implement EU MDR labeling activities within enterprise labeling infrastructure. Align labeling project plans with overall EU MDR program plan, coordinate with other workstreams to ensure overall program success. Prepare and facilitate meetings with business leadership to report status and present issues for decision-making Coordinate global project to ensure local execution of new labeling activities The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. Education : Bachelor's degree Experience : 5-7 years of experience in medical device or pharmaceutical labeling management, supply chain processes, and/or regulatory Strong Knowledge of medical device industry labeling requirements Excellent project management skills and attention to detail, PMP certification preferred Ability to lead and collaborate well with cross-functional business partners across a large matrix organization Display leadership skills and comfort working with executive leadership Ability to acknowledge issues or problems and work quickly to identify solutions Ability to work comfortably in a fast-paced environment Knowledge of core Microsoft Office software including Word, PowerPoint, Excel and Project - provided by Dice

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