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Label Standards Specialist Cincinnati, OH, USA * Mason, OH, USA * Virtual Req #2058 Thursday, April 25, 2024 AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure. We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally. POSITION SUMMARY: MUST LIVE IN GREATER CINCINNATI AREA The Label Standards Specialist will be responsible for the overall visual elements of the device product labeling. This includes the pad printing, IFU graphics content, label brand standards, and alignment with appropriate external regulatory requirements. This position will be responsible for the standardization and harmonization of the product, the product IFU and the on-product labeling with the corporate graphics/brand standards. This position will also implement and use standard templates to harmonize the look and feel of AtriCure corporate IFUs. This position is also responsible for input to the device packaging for the harmonization between the packaging and the labeling. This position is hybrid and 2-3 days per week require working out of the Mason office. ESSENTIAL FUNCTIONS OF THE POSITION: Responsible for overall design of the visual elements of on-product labeling. Responsible for the synthesis of that design with the overall corporate brand management standards. Primary point of contact for in-IFU and on-label visual design elements, including usability graphics, system screenshots, figures, etc. Leads integrations and special projects for the product labeling team pertaining to consolidation and harmonization of corporate brand management with on-product labeling. Assist cross-functional activities with input from Engineering, Operations, Product Marketing, Corporate Marketing and Regulatory Affairs to ensure all labeling requirements are understood and fulfilled when introducing the look of new product development, regardless of geographic region. Work directly with other functions to ensure their needs are met and incorporated into on-product labeling graphics and other visual elements. Identify and lead continuous improvements through the AtriCure CAPA process. Act as a liaison between the product labeling team and the R&D organization for graphics content within IFUs and on-product labeling. Act as a liaison between the Engineering Operations organization and the Product Marketing organization. Act as a liaison between the Engineering Operations organization and the Corporate Marketing organization. ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION: Regular and predictable work performance Ability to work under fast-paced conditions Ability to make decisions and use good judgement Ability to prioritize various duties and multitask as required Ability to successfully work with others Additional duties