Medical Device Regulatory Affairs SME

Chicago, IL

Job ID: 129485 Industry: CLINICAL


Medical Device Regulatory Affairs SME

Project Description:                                                     

Our client is a large medical device company and is in need of a regulatory affairs project manager to join their team.  The manager needs someone to come on site and be the point person on a specific project.  This person will be responsible for a 510K prep, where the resource chosen for the role will be reviewing the 510K and track & follow the deliverables.   


Day to Day Responsibilities:

This consultant will be responsible for helping the client drive and complete a project surrounding a 510K submission.  This consultant will be conducting document review, gap assessments, talking to R&D about the gaps found, review protocols & reports, etc.  The purpose of the role is to bring someone on who can conduct an independent review of the whole 510K package, identify gaps, clearly communicate them to the parties involved and drive the completion of the 510K. 

Required Skills:

Medical Writing

Regulatory Affairs


Job Type: Contract

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