Our client is a large Medical Device manufacturer. They develop and manufacture a number of Class II & III orthopedic products.
They are currently looking for a strong Project Manager to support the Supply Chain Workstream within their EU MDR Compliance Initiative.
Project Scope & Responsibilities :
The Project Manager will come from a Medical Device background, and should have strong experience in Project Management, IT Quality / Compliance / CSV, Supply Chain, Labeling and Change Control.
The client has identified the need to update Software Verification & Validation documentation and User Requirements documentation for two homegrown Labeling Systems as well as for their ERP System for Printing & Production, in order to be compliant with the new EU MDR requirements.
This Project Manager will be responsible for coordinating and managing this process, and will be the primary liaison between the IT and Supply Chain groups to ensure this is done effectively and efficiently.
As such, this individual must be able to work cross-functionally. This individual should understand CSV & IT Quality requirements (ideally for Labeling Software / Systems), as they will be responsible for gathering V&V and User Requirements documentation and ensuring User Acceptance testing is done on-
time and the proper deliverables are met.
The client also aims to introduce Robotic Process Automation to their process for creating / changing labels later in the project, and as such it would be a huge plus if this individual has experience with Robotic Process Automation (RPA).
It would also be a plus if this individual has a PMP Certification, as well as any experience or knowledge of EU MDR (previously known as Medical Device Directive / MDD).Required Experience :
Job Type : Contract