Ivd / Ivdr Project Manager

Project Manager - IVDR - Performance Evaluation Coordinator
This candidate needs to have strong Medical Device exp (no Pharma/Bio) and has a good medical writing/technical writing background.
They will be evaluating documentation and needs to be strong with performance evaluations, document creation and have a demonstrated PM background to manage this process.
Key skill sets are: Medical Device, Writing and PM background, EU experience

*****Please no 3rd party vendors*****
*****No out of state candidates.*****
*****Do not apply unless you are qualified for the position*****

Location:

Onsite in Chicago, IL - if you are not able / willing to work onsite - please do not apply.
Target Pay Rate:

$60 - $70/hour

Project Manager - IVDR - Performance Evaluation Coordinator
Our client in Illinois, a diagnostics company, is looking for a Performance Evaluation Coordinator (PEC) to assist in their IVDR efforts. They want the resource to be strong on the program management/coordination side, but not so fully strategic that they can't execute which is extremely important to them.

It's important that the resource has familiarity with the analytical and chemical aspects of diagnostic devices as they relate to product development and R&D. They would really also like this person to have SharePoint skills as the current system they are using is not useful and would like to bolster.

Aspects of this role include:
Technical Writing skills
Literature review of scientific validity reports which is reviewing associated device with chemical conditions and then performing the actual writing assessment of it
Reviewing and executing IVDR technical files (clinical performance, scientific literature, protocol reports, labeling reports)
Project coordinating aspects of the IVDR program based on scientific literature review and resulting writing assessments
SharePoint skills

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