Medical Device Complaint Handling Specialist

Miami, FL

Industry: Medical Device Job Number: 133739


Medical Device Complaint Handling  Specialist 

Environment:  Our client is a large Medical Device manufacturer that develops a number of Class II & III Medical Devices. They are currently in need of a Complaint Handling Specialist to provide expertise in Complaint Handling & Medical Device Reporting.

Responsibilities: The Complaint Handling Specialist will come from a Medical Device background with hands-on experience in Complaint Handling and Medical Device Reporting (MDR). This individual will be supporting both Complaint Remediation activities as well as  dealing with a high volume of real-time complaints, and must be able to hit the ground running. This candidate should have experience in Complaint Handling & MDR  for Class II & III medical devices, and should have experience making Reportability Assessments/Reportability Determinations. It would  be a plus if the candidate has a  Clinical background or Nursing experience. It would also be a plus if this  individual has used  SmartSolve  Complaint  Management Software (a Pilgrim system). It is extremely important that this individual is a quick learner and can work in a fast-paced environment with minimal supervision.

This individual will have responsibilities including but not limited to: Complaint Handling (Open-Close),  Reportability/Determination, Complaint Coding, Severity/Harm Assessment, Complaint Investigations, and MDR.

  • Medical Device
  • Complaint Handling 
  • Medical Device Reporting (MDR)
  • Reportability Assessment/Reportability Determination

  • Clinical/Nursing  Experience
  • Complaint Investigations Experience
  • Cardiology/Endovascular Complaints Experience
  • SmartSolve  Complaint  Management Software

Job Type: Contract  

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