Regulatory Affairs EU MDR

Trenton, NJ

Job ID: 128939 Industry: CLINICAL

 

Regulatory Affairs SME (EU MDR)

Project Description:                                                     

Our client is currently in the process of conducting a gap assessment for their regulatory technical files.  They are looking for a consultant to come on board and help conduct the gap assessment for their regulatory documents in regard to the new EU MDR guidelines.  They are looking for someone who has experience working with the new European directive specifically.

 

Day to Day Responsibilities:

This consultant will be responsible for helping the client conduct a gap assessment of their regulatory technical files.  They want someone who comes from a regulatory affairs background who has worked with class IIb  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. 

Required Skills:

Regulatory Affairs

EU MDR Guidelines

 

Job Type: Contract

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