Remediation Project Manager

Mansfield, MA

Job ID: 131918 Industry: 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 own about 5-6 Tech Files and will be responsible for driving project activities to ensure  their Tech Files are successfully remediated. As such, this individual  must have experience working with cross functional teams, tracking deliverables, project timelines  and driving results. 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 

Job Type: Contract

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