IVD Regulatory Affairs SME

Rochester

Job ID: 125774 Industry: CLINICAL

          

IVD Regulatory Affairs SME

Project Description:                                                     

Our client is currently in need of a SME in IVD Regulatory Affairs.  Specifically, they are looking for someone who has experience implementing the new guidelines around replacement reagent and instrument family policy.  The client is unfamiliar with the new guidelines and needs someone to provide expertise on how to implement them.

 

Day to Day Responsibilities:

This consultant will be responsible for taking the information needed from the client, perform a gap analysis and provide SME advise on how to implement the replacement reagent and instrument family policy guidance’ s.   The client needs someone who has done this recently as the guidelines have changed within the last year or two.  This person will be on call for the client as the project continues.

Required Skills:

Medical Device Regulatory Affairs

replacement reagent and instrument family policy

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