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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