Project Manager (with MD) (19-00484) – CA – Irvine

Scope of Work:
Our client is a large medical device manufacturer. They manufacture a number of Class II & III medical devices. They are in need of a Project Manager to lead the client' s EU MDR project by bringing the client' s Technical Files into compliance with the new EU Medical Device Regulations (EU MDR, formerly known as MDD).


The consultant will be a Project Manager with a strong background in Medical Device Regulatory Compliance/Regulatory Affairs, specifically for the EU. The PM will be responsible for overseeing and driving the client' s initiative of updating Technical Files/Dossiers to achieve compliance with new EU Medical Device Regulations, and re-registering the client' s medical devices in the EU.
The consultant must have strong Project Management skills, experience working with cross functional teams, tracking deliverables, and driving results. However, the consultant must also be able to roll up their sleeves and help with remediation of documents if need be. They must understand the critical path to remediate technical files in the EU, so experience with EU regulations for Medical Devices is a must.

Source: Job Diva – Job Listing

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