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MDR (Medical Device Regulation) Project Manager

eTeam Inc.

Posted on Dec 18, 2020 by eTeam Inc.

Cork, Ireland
IT
Immediate Start
Annual Salary
Full-Time


Job Title: MDR (Medical Device Regulation) Project Manager
Location: Cork, Ireland
Type: Permanent role

Project management:

  • Experience in creating project plan, resource plan and project risk management
  • Collaborate with project leadership on identification and allocation of activities between internal and external resources and assign work accordingly
  • Collaborate with project stakeholders identification EU-MDR deliverables
  • Understand MDR impacts to assigned product portfolio and communicate to team members accordingly
  • Coordinate priorities with other EU MDR work streams to feed into the overall success of the EU MDR program
  • Tracks progress of product development in the context of the program
  • Has a combination of global and regional accountability
  • Responsible for conducting a Gap assessment as per current risk management documentation & trace matrices against new EU MDR Standards
  • Excellent Communication & Interpersonal skills in coordinating, project planning, scheduling, tracking and interaction with cross-functional teams,
  • Responsible for overall delivery of the project

Technical experience:

  • Hands on experience in Manufacturing engineering/process engineering for medical devices/similar mechanical component
  • Hands on experience in Equipment qualification/Process validation/Test methods validation/Risk management
  • Hands on experience in change control process (ECO process) to introduce new changes to the existing manufacturing processes
  • Hands on experience in documentation such as protocols, manufacturing controls plan & test reports
  • Hands on experience in creating risk management document such as pFMEA
  • Expert in Process validation/Cleanroom Packaging process/Cleanliness/Foundry process/mechanical manufacturing process
  • Good knowledge in CTQ, Control Plan & Validation Plan Documentation

Additional preferences

  • Knowledge on exp. in Process transfer/new product introduction
  • Experience in GAP Assessment and reports
  • Knowledge in ISO13485/EUMDR/21CFR regulations
  • Knowledge in root cause analysis using any suitable quality tools



Reference: 1039345757

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