Product Safety Specialist

AtriCure • Mason, OH

2d

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

Benefits

• 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
• full access to our on-site fitness center and cafeteria

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees