Job title: Associated MDR/Vigilance Specialist
Location: Mounds View, MN
Duration: 12+ months (Possibility of extension)
ROLES & RESPONSIBILTIES
· 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 Cardiac Rhythm and Heart Failure Management (CRHF) products to determine complaint status and regulatory reportability.
· In addition, this position supports the ongoing monitoring of product performance.
· Works cross-functionally to ensure maintenance and review of events and complaints, reporting of Medical Device Reports (MDRs), ADE data, or adverse reaction data, 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.
· Supports and represents complaint handling in internal and external audits and inspections.
As part of the Cardiac and Vascular Group Product Experience Management organization, we seek candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes and systems by being accountable, having a voice, and taking action.
POSITION RESPONSIBILITIES:
• Electronically process events to determine complaint and reportability status. Complete applicable Medical Device Reports (MDR) as required per internal policy & procedures and FDA regulations.
• Ensure complaint investigations are adequate, accurate, detailed and timely.
• Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint.
• Collaborate with appropriate technical, Clinical, Field/Sales and/or returned product analysis employees to determine reporting eligibility.
• Complete electronic submission of MDRs to the FDA.
• Ensure accurate data entry, scanning, and retention of documents to complete event files.
• Support internal systems, methods, and procedures to maintain compliance.
• Develop and maintain product knowledge of CRHF products.
***Required***
· Bachelor's Degree
· At least one year experience in a health, clinical, technical, or scientific field
· Can work independently in a team environment
· Attention to detail