MDR/Vigilance Specialist

Location: Mounds View, Minnesota
Posted On: 7/8/2017
Job Code: 2394-MN-MDR
Job Description
The MDR/Vigilance Specialist participates in the company's medical device and/or drug surveillance platform; including the intake, evaluation, processing, and follow-up on product performance events, complaints, and adverse reports.
The MDR Specialist analyzes events reported from multiple inputs on Structural Heart products to determine complaint status and regulatory reportability.
Works cross-functionally to ensure maintenance and review of events and complaints, reporting of Medical Device Reports (MDRs) as set forth by the FDA and other regulatory agencies.
Requires follow-up internally and externally to assure complete and accurate event files, complaint detail, and product performance information. Receive and document product events reported by customers and field representatives.
Determine if event is a product complaint. Enter all information related to the events into the complaint database. Maintain files that meet the QSR and Corporate requirements. Facilitates complaint communications and assess for regulatory reportability and potential impact to patient safety and business operations.
Category:Non-IT  code:new
Job Requirements
Medical Device Reporting, Complaint Handling

Not Ready to Apply?
Contact Details
Nitin Buxani
E-mail Address