Medical Device Complaint Handling Specialist

Miami, FL

Industry: Med Job Number: 129679

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 dealing with a high volume of real-time complaints as they come in, and must be able to hit the ground running. This candidate should have experience performing these activities for Class II & III medical devices, and 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), Regulatory Reporting Determination, Complaint Coding, Severity/Harm Assessment, Complaint Investigations, and MDR.

  • Medical Device
  • Complaint Handling 
  • Medical Device Reporting (MDR)
  • FDA Regulatory Requirements

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

Job Type: Contract   

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