MDR/Vigilance Specialist

Location: Minneapolis, Minnesota
Posted On: 9/15/2017
Job Code: MDR / Vigilance - Mi
Job Description
Successful performance requires a sound basic knowledge of the individual scientific discipline and the ability to apply fundamental principles and techniques to the problems assigned.

Reponsible for the intake, documentation, Medical Device Reporting, and investigation of complaints for legacy Neuromodulation products in accordance with applicable internal procedures (work instructions) and external requirements (regulations or guidance from any and all regulatory bodies).

• Receive and assess product comments to determine need for complaint handling record.
• Document required information in Global Complaint Handling (GCH).
• Assess complaint file for missing required information. If information is missing, initiate attempts to gather information. Steps may include contacting: client Field Personnel, Health Care Providers, & patients or other initial reporters
• Communicate with outside parties in a professional and customer-focused manner that is in following with our Mission and enhances the client brand.
• Evaluate incoming product events to determine MDR and Vigilance reporting eligibility.
• Initiate, complete regulatory reports for timely submission to FDA and other regulatory bodies.
• Determine if investigation is necessary. If investigation is necessary, determine: potential cause and contributing factors to the alleged event, device relationship, and if formal device investigation is necessary.
• Summarize the results of any investigation.

4 year degree required. No experience needed, will train on the job.
Attention to detail, good team player, & like a regulated industry/job.
Category:Non-IT  code:new
Job Requirements
MS Office

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Contact Details
Chirag Sharma
E-mail Address