Job Information
Atricure, Inc. Product Labeling Specialist in Cincinnati, Ohio
Product Labeling Specialist Cincinnati, OH, USA * Dayton, OH, USA * Mason, OH, USA Req #2129 Friday, June 14, 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/Title: Product Labeling Specialist Department: Quality Assurance Reports To: Product Labeling Manager 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 atte