Post-Market Surveillance Risk Management Consultant
Post-Market Risk Management Consultant (EU MDR)
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.
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.
- Medical Device
- Active Customer Feedback Process
- Post Market Surveillance
- Post-Market Risk Management
- Global Project Experience
- EU MDR
- Clinical/Nursing Background
Job Type: Contract