Aerotek Complaint Handling Specialist in Dallas, Texas
We are looking to hire Complaint Handling/Medical Report Specialists immediately!
The candidates will perform complaint management which includes independently determining and filing appropriate medical devices reports with various regulatory agencies; entering of complaints into the database; participating on cross-functional teams; and providing information on product complaints to various teams.
Initiates and manages the complaint file
Maintains accurate entry of complaints in the database
Communicates verbally and in writing both internally and externally to field representatives regarding information needed specific to product complaints (e.g. physicians, hospital personnel, sales representatives, international offices)
Independently performs investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints
Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities) and sends reports within required timeframes, consulting as needed with management
Participates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross-functional complaint teams, new product teams, risk management meetings)
Provide support to the Legal Department regarding product complaints
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
4-year degree, preferably in the healthcare (e.g. cardiac nursing, cath lab experience), science, or technical fields; or 2-year degree and 10 years of relevant experience supporting complaint handling investigations, medical device reporting, product evaluation, or related work
Knowledge of global regulations for medical device reporting and medical terminology is a plus
Strong written and oral communication skills are required
Good problem-solving and proficient computer skills are required
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit aerotek.com .
Aerotek is acting as an Employment Agency in relation to this vacancy.
Location: Dallas, Texas
Posting ID: 5794066-1726