Miami, FL

Industry: Quality Job Number: 120147



Environment:  Our client is a large medical device manufacturer that develops a number of Class III Ventricular Assist Devices (VAD) for Congestive Heart Failure Management. They are currently in need of an MDR SME with a focus on upstream MDR work such as Summary Reporting, Coding & Determinations for an on-going remediation project.

Responsibilities: The client is currently in the midst of an on-going remediation project stemming from an FDA Warning Letter. They currently have a substantial backlog of complaints and associated MDR’ s. They have just reached phase 2 of the project, and now need an MDR SME to provide expertise and support in the upstream MDR process. This is including but not limited to: MDR Summary Reporting, MDR Coding & Determinations, Severity/Harm Assessment, Inputting MDR data into eSubmitters and Excel. The consultant will need to understand the Regulatory requirements associated MDR’ s from a domestic and international perspective.

It is imperative that this individual has strong interpersonal skills and is able to work well in a team atmosphere.

  • Medical Device
  • MDR Summary Reporting
  • MDR Coding
  • MDR Determinations

  • Class III Cardiology Devices
  • Remediation Experience

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