Product Safety 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:

This position will be responsible for product complaint processing and safety reporting-events. The role will support complaint coordination, maintaining complaint files, reporting and ensuring the accuracy of safety data.  Also communicate with field-based employees, distributors and customers concerning returns, and possible complaints concerning AtriCure products.  He/she will initiate Return Goods Authorizations (RGAs), record and conduct periodic review and follow-up to promote prompt return of the products.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Oversee complaint intake, documentation in the system of record, tracking, and closure.
• Evaluate complaints for MDR requirements and determine when to present to the MDR committee.
• Prepare MedWatch and other required regulatory reports and support timely submission to FDA/global authorities.
• Assist in safety-related regulatory reporting to global health authorities
• Initiate RGAs, case intake and complaints in AtriCure’s complaint management system as appropriate
• Communicate with customers, and others 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
• 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

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 preferred or demonstrated equivalent combination of education, training and experience.
• Three years of relevant experience, preferably with Medical devices industry, hospital setting or clinical background.
• Strong interpersonal communications skills
• Ability to prioritize tasks and complete work with minimal supervision
• Computer/Proficient knowledge of Microsoft® Office applications (Word, PowerPoint, Excel, Outlook, etc.);
• Working knowledge of guidelines and FDA regulations (is a plus)

PREFERRED QUALIFICATIONS:

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

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

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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: 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).