MDR/Vigilance Specialist

Location: Mounds View, Minnesota
Posted On: 7/6/2017
Job Code: 7460_MDR_MN
Job Description
Position 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. Request additional information as needed for complete understanding of the event. 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.
• Completes and submits regulatory reports within the time-frames mandated by the FDA.

Preferred Qualifications:
• 1-3 years of related work experience
• Clinical and/or regulatory background.
• Multi-task management
• Effective priority setting
• Excellent knowledge of word processing, spreadsheet, and database use.
• Advanced oral and written communication skills
• 4 year degree (science background a plus)
Category:IT  code:new
Job Requirements
Complain handeling,word processing, spreadsheet, and database use

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Contact Details
Sparsh Patel
E-mail Address