Post-Market Surveillance Risk Management Consultant

Miami, FL

Industry: Medical Device Job Number: 134790

  Post-Market  Risk Management  Consultant (EU MDR)

Environment:
Our client is a global manufacturer of Medical Devices. They are currently in need of a Post-Market Surveillance Risk Management Consultant to support their EU MDR compliance initiative.

Job Duties/Responsibilities:
The Post-Market Risk Management Consultant will initially be tasked with developing a robust Active Customer Feedback Process from scratch. This Customer Feedback Process is critical to our client’ s Post-Market Surveillance activities and has been designated as an area our client is currently non-compliant by BSI (our client’ s Notified Body). Although the client doesn’ t have a formal Customer Feedback Process in place currently, they still perform Active Customer Feedback activities. It will be the responsibility of this consultant to review these activities to understand: what information our client looks for from customers, and how they obtain this information from customers. The consultant will then use this information to develop and implement a formal Active Customer Feedback Process.

Once this initial portion of the project has been completed, the consultant will then perform a GAP Assessment of our client’ s current Post-Market Surveillance Risk Management procedures, and then update/remediate as needed to achieve an EU MDR compliant Post-Market Surveillance Risk Management process. Once complete and implemented, this individual will support the implementation of this process for two other business units.

Required:
  • Medical Device
  • Active Customer Feedback Process
  • Post Market Surveillance
  • Post-Market Risk Management
  • Global Project Experience

Plus:
  • EU MDR
  • Clinical/Nursing Background

Job Type: Contract

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