Medical Device Quality Project Manager (EU MDR)

Jersey city, NJ

Job ID: 129391 Industry: Med


Medical Device Quality Project Manager (EU MDR)

Project Description:                                                     

Our client is currently in the process of conducting a gap assessment for their  technical files, to adhere to the new EU MDR Regulations from a Quality perspective.  They are looking for a project management consultant to come on board and help conduct the gap assessment for their  documents in regard to the new EU MDR guidelines.  They are looking for someone who has experience leading a program around setting up the new EU MDR. This consultant should be well spoken, have excellent time management skills, experience working cross functionally and managing projects efficiently. 


Day to Day Responsibilities:

This consultant will be responsible for helping the client conduct a gap assessment of their  technical files.  They want someone who comes from a Quality, Design, DHF, etc.  background who has worked with class II  or class III  devices.  They will be working with different workstream leads to help them understand where the gaps are, develop a strategy on how to close those gaps, and then help execute against the strategy.  It is crucial that the consultant chosen has significant experience working with the new EU MDR guidelines, and is a true project manager.

Required Skills:

Quality: Design Control, DHF, etc.

Program Management

EU MDR Guidelines


Job Type: Contract

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