Product Safety Specialist

AtriCure•Mason, OH

About The Position

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.

Requirements

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)
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

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

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
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