Medical Device Regulatory Affairs SME


Job ID: 125772 Industry: CLINICAL


Medical Device Regulatory Affairs SME

Project Description:                                                     

Our client is currently in need of a SME in Medical Device Regulatory Affairs to help with a few different projects.  The first project involves handling the submissions involved in  moving manufacturing from one site to another for IVD Class I and Class II products.   The second project is the client has acquired some assays from a third party and are responsible for the regulatory guidance of them.  They are looking to move the responsibilities to another third party over time.  The client is looking for someone who can oversee both initiatives from a regulatory stand point.  


Day to Day Responsibilities:

This consultant will be responsible for overseeing both projects mentioned above.  Right now, the client is short staffed and cannot dedicate a full time resource to oversee both projects.  They will need the consultant to be responsible for managing both initiatives and do so without little to no management.  The consultant chosen for this role will have had experience moving manufacturing sites and working with the regulatory documents needed for this to happen along with managing assays acquired from a third party.

Required Skills:

Medical Device Regulatory Affairs

Class I and Class II


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