Product Labeling Specialist

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:

Reporting to Product Labeling Manager, the Product Labeling Specialist, will be a member of the overall Quality team and is responsible for the execution of the processes related to the development of and modifications to the Company’s product labeling. 

ESSENTIAL FUNCTIONS OF THE POSITION:

• Creation of and modification to product labeling following local procedures and ensuring labeling content is compliant with FDA, GMP, ISO and other applicable standards and regulations.
• Execution of optimization and continuous improvement activities - both in content development and execution in Manufacturing
• Drive continuous improvements through observation, measurement and root cause analysis/resolution
• Aide in the development and documentation of new processes which support speed, cost reductions and quality improvements
• Participate in audit related activities, gap assessments and mitigation support
• Represent the labeling team as a subject matter expert on project teams as necessary.
• Cross functional collaboration with Operations, Marketing, Sales, Product Development, Regulatory and Clinical functions
• Meet personal and corporate objectives
• Manage key internal and external partnerships, including relationships with customers, vendors and contract engineering firms
• Ensure commitment to functional excellence and the ability to execute positive changes
• Basic project management skills needed for the management of small size projects within the departments scope of work.

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 judgment
• Ability to prioritize various duties and multitask as required
• Ability to successfully work with others
• Additional duties as assigned

BASIC QUALIFICATIONS:

• Associates or Bachelor’s degree from an accredited college or university.
• Minimum of 3 years of experience in Product Labeling in the medical device industry
• Experience leading/managing small projects
• Knowledge of Design Controls and experience with FDA QSR 21 CFR Part 820, ISO 13485 and EUMDR
• Ability to work with both internal and external partners
• Excellent written and verbal communication skills
• High level of attention to detail
• Ability to demonstrate proficiency in issue resolution and problem solving
• Ability to multi-task and work with direction
• Ability to manage multiple priorities
• Basic understanding regarding labeling regulations and guidelines, including UDI 21 CFR 830 and EUMDR
• Label software (i.e., Bartender, NiceLabel, etc.) experience

Working knowledge of Adobe Suite of Products (indd, illustrator, pdf editor) Change control experience

PREFERRED QUALIFICATIONS:

• UDI requirement knowledge and some associated experience
• Ability to use MS Project to manage timelines and resource requirements

OTHER REQUIREMENTS:

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

#LI-RD1

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: https://www.atricure.com/careers-atricure/benefits. AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov/ AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. 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).