Medical Device QA/RA EU MDR

Minneapolis, MN

Industry: Medical Device Job Number: 132679

Medical Device QA/ RA EU MDR Consultant

Project Description:                                                     

Our client is a Medical Device, Pharmaceutical and OTC manufacturing company. They are currently beginning their gap assessment for the new EU MDR regulations, and starting their efforts to become compliant. They are seeking a high level consultant to perform a technical gap assessment of 5 of their technical files (design dossiers and binders)  to provide insight and suggestions into the course of action they need to take to remediate.

Most importantly, this consultant must have working experience doing this type of work for another large international organization.

Day to Day Responsibilities:

This consultant will help the client begin its current state assessment for compliance to EU MDR. They will perform a very technical gap assessment of their technical files. This person should come from a background in the Medical Device industry, but it would be ideal if this person had exposure to one or more of the following; Combo, Pharma, Cosmetics and OTC. This person will be looking at DHF’ s, Supplier Records, and Registrations. A lot of these products are 30+ years old with potentially incomplete documentation.

Most importantly, this consultant will be working to go deep into the clients technical files and provide technical feedback on how to proceed.

Required Skills:

Expert Knowledge of EU MDR

Technical File remediation experience

15+ years of Medical Device Experience

Working Regulatory knowledge

Understanding of expectations from notified bodies (FDA, BSI, etc.)

Deired:

- Medical Device, Combo, Pharma and OTC experience.

Job Type: Contract 

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