POSITION SUMMARY:

This position will be responsible for product complaint processing, safety reporting events, and global post-market surveillance activities. 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 the collection, processing, and tracking of complaints
• Evaluate complaints for Medical Device reporting requirements
• Preparation of MedWatch report and submission to FDA
• Assist in safety-related regulatory reporting to global health authorities
• Initiate, facilitate and oversee global post-market vigilance responsibilities, such as PSURs, regional reporting, EU MDR Article 88 trending and other post-market surveillance requirements
• Assist in maintaining tracking tools for MDRs and literature events
• 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 required or demonstrated equivalent combination of education, training and experience (preferably with medical devices industry, hospital setting or clinical background).
• Strong interpersonal communications skills
• Good documentation and professional writing 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 strongly preferred

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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