Complaint Handling Specialist

Foxborough, MA

Job ID: 132024 Industry: Medical Device

 

Complaint Handling  Specialist

Environment: 

Our client is a large Medical Device manufacturer that develops a number of Class I & II  Medical Devices. They are currently in need of a Complaint Handling Specialist to provide support a Complaint Remediation project.  

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 backlogged  complaints, so they must be comfortable working in a fast-paced remediation environment. This candidate should have experience performing these activities for Class I & II medical devices, and it would  be a plus if the candidate has a  Clinical background or is a Registered Nurse. 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 hit the ground running  with minimal supervision.

This individual will have responsibilities including but not limited to: Complaint Remediation,  MDR, Reporting Determination, Complaint Coding, Severity/Harm Assessment.

Required:
  • Medical Device
  • Complaint Handling 
  • Medical Device Reporting (MDR)
  • Global Regulatory Requirements
  • Remediation Experience

Plus:

Registered Nurse

Job Type: Contract

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