UDI Consultant (EU MDR)

Boston, MA

Industry: Medical Device Job Number: 134699

 

UDI Consultant (EU MDR)

Our client is a large Medical Device manufacturer.  They develop and manufacture a number of Class II & III orthopedic products. They are currently in need of a UDI Consultant to help ensure existing documentation meets new UDI requirements for EU MDR compliance

Project Scope &  Responsibilities:

The client has already formed an internal team which has conducted EU data planning sessions and now has a plan in-place for gathering, publishing and documenting the methods for support & maintenance of EUDAMED. The UDI  Consultant will be responsible for:
  • Manage on-going Labeling and DPM (Direct Part Marking) challenges.
  • Manage PO’ s and tracking spending to budget in Ariba (SAP Procurement & Invoicing  Software Tool),
  • Lead management of platform for collecting and updating GDSN data (Global Data Synchronization Network).
  • Lead Core Team Meeting and track to completion open work-stream activities.
  • Develop plan to close EU-MDR gap assessment and follow to completion all process/work instruction changes. 
  • Liaison with Heartbeat team to stay on top of new requests requirements for GDSN.
  • Take point on day-to-day UDI issues as they arise.
  • Support other Global UDI planning, data gathering, tracking, etc. as needed for client.

Required:
  • Medical Device
  • UDI (Unique Device Identifier)
  • Labeling
  • Direct Part Marking
  • Global Supply Chain

Huge Plus:
  • EU MDR UDI/EUDAMED  Experience

Job Type: Contract

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