MAIN RESPONSIBILITIES

　　Product Surveillance Analyst is responsible for Medical Device Report (MDR) submission documentation and follow-ups, and will include interaction with Complaint Coordinators, Failure Analysis, Servicing, Customer Service, etc.

　　Performs all activities pertaining to receiving and investigating reports of worldwide complaints/events on a variety of products; entering information into the complaint database; independently determining and filing appropriate medical devices reports with various regulatory agencies; participating on cross functional teams; and providing information on product complaints to various teams (e.g. Regulatory, Quality Engineering).

　　Analyzes and resolves customers technical and clinical questions regarding company products.

　　Corresponds with customers regarding the results of inquiries and analysis of products.

　　Uses discretion in escalating unusual product performance issues, collaborates with engineering, resolves customer complaints.

　　Participates in product improvement teams, field failure analysis and other analytical teams responsible for the improvement of products and regulatory issues.

　　This position requires a very high degree of technical competence and communicative ability in order to receive, evaluate, investigate and respond to customers' questions and complaints.

　　Ensures accurate department procedures and work instructions are maintained

　　Train new employees to the complaint handling process

　　Provide support to the Legal Department regarding product complaints

　　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

　　QUALIFICATIONS

　　Education

　　Bachelor's Degree preferably in clinical / Medical / Scientific discipline or equivalent.Experience/Background

　　Knowledge in Medical Terminology is fundamental to the role.

　　Average of 1-2 years in customer support or complaint handling experience would be advantage to this position.

　　Strong PC/Data Entry Skills required.

　　A high degree of interpersonal relations skills, with strong verbal and written communication skills in English language.

　　Good Problem-Solving Skills: Must be able to work under pressure and stress common to office environments; maintain a high degree of accuracy and analytical thinking; and with ability to deal effectively with problems and customers on the telephone.

　　An Equal Opportunity Employer

　　Abbot welcomes and encourages diversity in our workforce.

　　We provide reasonable accommodation to qualified individuals with disabilities.

　　To request accommodation, please call 224-667-4913 or email [email protected]