Label Standards Specialist

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 as assigned

BASIC QUALIFICATIONS:

• Bachelor’s degree in Graphic Design or related field
• 3 – 5 years’ experience in graphic design, product labeling, or other digital artistic field.
• Expertise in Medical Device product labeling processes.
• Familiarity/expertise in Adobe Illustrator, InDesign and/or Photoshop.
• Strong interpersonal, analytic and communication skills at multiple organizational levels

PREFERRED QUALIFICATIONS:

• Working knowledge of worldwide label requirements, including EU MDR and 21 CFR.
• Understanding of UDI standards.

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as required
• Ability to occasionally bend and push/pull as needed
• Ability to occasionally lift up to 25 pounds
• Ability to pass pre-employment drug screen and background check

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