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Analyst II, Postmarket Surveillance

Company: ATR International
Location: Minneapolis
Posted on: November 23, 2021

Job Description:

We are seeking a Analyst II, Postmarket Surveillance for a very important client. Initiates and manages the complaint file, maintains accurate entry of complaints in the database, communicates to field representatives regarding information needed specific to product complaints (e.G. physicians, hospital personnel, sales representatives, international offices), independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g. FDA, ECA) and submits reports within required timeframe, diligent of any unusual trends in product complaints and communicates them with mgmt., complies with US FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments, Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors. Performs other related duties and responsibilities as assigned - Working with complaints on devices - File managing role - Strong organizational skills - Self created scheduleJob Requirements:

  • Manage monitoring vendors and partners
  • Provide tracking and monitoring services to JCS
  • Identify business requirements for monitoring applications
  • Maintain monitoring tools and standardized forms
  • Approve a percentage of monitoring visit reports
  • Provide backup support for daily overdraft monitoring
  • Troubleshooting for one or more monitoring tools
  • Manage and conduct multiple simultaneous monitoring initiatives
  • Create repeatable monitoring processes and supporting documentation to drive consistency and repeatability of all monitoring projects
  • Train local staff in monitoring and evaluation techniques
  • Reviewing triggering activity in transaction monitoring systems/reports
  • Integrate disparate technology solutions into the monitoring paradigm
  • Assist and support Audit and monitoring protocols
  • Complete other Credit Support monitoring duties
  • Configure and maintain network and server monitoring infrastructure
  • Ensure compliance with the protocol and approved monitoring plan
  • Participate in development and implementation activities for monitoring applications
  • Provide training to other analysts working on a monitoring project
  • Provide information from monitoring studies to facilitate remedial activities
  • Provide information for condition monitoring lead tracking and resolution

Keywords: ATR International, Minneapolis , Analyst II, Postmarket Surveillance, Professions , Minneapolis, Minnesota

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