Medical Device Remediation Project Manager

Boston, MA

Industry: Medical Device Job Number: 146742

 

Medical Device  Remediation Project Manager

Environment:

Our client is a large medical device manufacturer. They manufacturing a number of class 2 and 3 orthopedic medical devices. They are currently in need of a Project Manager to support a Tech File Remediation initiative in an effort to achieve EU MDR compliance.

Duties/Responsibilities/Scope of Work

The consultant will be a Project Manager with background in Medical Device R&D/Design/NPD, as well as Technical File Remediation, Design Quality/Design Control, and Risk Management. The Project Manager will have about 10 engineers reporting indirectly to them, each of which will be owning about Tech Files. The PM will be responsible for driving project activities to ensure their Tech Files are successfully updated to meet compliance. As such, this individual must have experience working with cross functional teams, tracking deliverable, project timelines and driving results.They will also be working with shared projects that relate to packaging and biocompatibility.  It is equally important that this individual has the ability to roll up their sleeves and help out with remediation from a technical perspective as needed  They must understand the critical path to remediate technical files/design dossiers in the EU, so experience with EU regulations for medical devices is a must.

Required:

Medical Device
Project Management
Technical File/Design Dossier Remediation
R&D/NPD Engineering Background
Design Quality/Design Control/Risk Management
EU Regulations
Microsoft Project, Excel, Word
 

Plus:
Spinal Medical Devices
EU MDR
Previous J&J remediation experience

Job Type: Contract

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