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 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 :

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.

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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AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 20 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more.

Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website : AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).

Other details

• Job Family Labeling
• Job Function Quality
• Pay Type Salary
• Employment Indicator Non Manager
• Required Education Bachelor’s Degree

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Last updated : 2024-04-28