Medical Device Clinical Complaints SME
Medical Device Clinical Complaint Handling SME
Environment: Our client is a large medical device manufacturer that develops a number of Class III Medical Devices. They are currently in need of a Clinical Complaint Handling SME to support Clinical Complaint Investigations, current and backlogged complaints, as well as domestic and international MDR’ s.
Responsibilities: The client is currently in the midst of an on-going remediation project. They currently have a 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 Clinical Complaints SME. 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. 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. It would be idea if the candidate individual understands Electrical Engineering, as this 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).
- Medical Devices
- Complaint Handling
- Class III Medical Devices
- Registered Nurse (RN)
- Cardiac Nurse/Open Heart Transplant Experience
- Remediation Experience
Job Type: Contract