Temporary Product Safety and Surveillance Coordinator

AtriCure • Mason, OH

6d • Onsite

About The Position

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. 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. This position will communicate with field-based employees, distributors and customers by telephone, email and other means concerning returns, requests for servicing and possible complaints concerning AtriCure products. He or she will initiate and communicate Return Goods Authorizations (RGAs), record them in the company’s systems, and conduct periodic review and follow-up to promote prompt return of the products. The Product Safety and Surveillance Coordinator will further obtain information necessary to determine whether the return involves a product complaint and, if so, will initiate and process a complaint following the company’s quality system procedures, and periodically monitor the complaint to ensure timely completion. The Product Safety and Surveillance Coordinator will ensure accurate and timely documentation of complaints and assist management in communicating with field-based employees, distributors and customers regarding the status of complaint investigations.

Requirements

• High school diploma required
• Good interpersonal communications skills
• Ability to prioritize tasks and complete work with minimal supervision
• Computer/Data Entry Skills, working knowledge of Microsoft Office applications (Word, PowerPoint, Excel, Outlook, etc.)

Nice To Haves

• Prior medical device complaint handling and/or product surveillance experience
• Basic familiarity with medical device quality systems and regulations
• Medical/clinical background or training

Responsibilities

• Receive return request from the field, distributors and customers, and issue return goods authorizations following company procedures
• Monitor open RGAs and follow up periodically by telephone and/or email as necessary to promote the prompt return of devices to AtriCure
• Evaluate return goods requests and initiate complaints in AtriCure’s complaint management system and applicable logs as appropriate
• Communicate with customers and others by telephone and email to gather information needed for complaint evaluations, and record that information promptly and accurately in appropriate systems
• Monitor complaint progress to ensure investigation completion in a timely manner.
• Assist in preparing ad-hoc and periodic complaint reports, as requested by management
• Support assigned compliance activities such as procedure updates, training, internal audits, etc.
• Provide additional support to Compliance, Risk Management, Quality and/or Regulatory Affairs functions as needed
• 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

Benefits

• Medical & Dental beginning day 1 of employment
• 401K plus match
• 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads
• Volunteer Time off
• Pet Insurance
• On-site fitness center and cafeteria (for Corporate-based employees)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED