Medical Device Clinical Complaint Handling SME

Miami, FL

Industry: Quality Job Number: 121465

Medical Device Clinical Complaint Handling SME


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 a Complaint Handling SME with a strong  Clinical background to support Clinical Complaint Handling for current and backlogged complaints, as well as domestic and international MDR’ s.


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. There is a team assisting in complaint closure and MDR filings, but the client is in need of a strong Complaints SME with a Clinical background to conduct deep dive investigations for particular complaint cases. This individual will be communicating with Surgeons and Physicians involved in the implant procedure to understand causal factors. For this, the individual MUST have Clinical experience specific to Cardiac procedures (ideally dealing with VAD’ s).This person must be able to adequately communicate with these clinical professionals from a technical and functional standpoint, and to analyze and report information on the complaints to upper management. This individual should also understand Electrical Engineering (as the VAD is a Class III Electrical Device and nearly all complaints are associated with electronic components of the device). This individual will have responsibilities including but not limited to: Complaint Regulatory Reporting Determination, Complaint Coding, Severity/Harm Assessment, Complaint Investigation (Clinical), Clinical Narratives, MDR/MDV and review.

The consultant will need to understand the Regulatory requirements associated with these complaints and MDR’ s from a domestic and international perspective (US, EU, Australia, and Canada).

Required Skills:
  • Medical Devices: 5-8 years
  • Complaint & MDR: 5-8 years
  • Clinical Background/Experience: 5-8 years
  • Registered Nurse (RN)
  • Class III Medical Devices

  • CVICU (Cardiovascular Intensive Care Unit) Clinical Experience
  • Cardiac Nurse/Open Heart Transplant Experience
  • Remediation Experience

Job Type: Contract  

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