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Regulatory Project Manager

Job description

Responsibilities

  • Lead global team to design and implement EU directive focused regulatory projects including gap analysis, training and site visits.
  • Project Initiation Document which includes the Project Schedule (MS Project), Project Plan, Project Risk & Issues Log, and Communication Strategy with Plan
  • Provide technical knowledge and support for the application of new regulations globally across several business units, managing the cross functional work required.
  • Create a culture of continuous improvement and learning on the program.
  • Establish meetings across global regulatory and quality leadership to ensure correct application and introduction of relevant regulatory processes and procedures.

Requirements

  • 3 years in a FDA or EU regulayted environment with experience with ISO13485/2016, IVDR EU 2017/746 and/or IVD CE Marking.
  • Third level degree in engineering, preferably quality or regulatory affairs.
  • Should have PMP, Prince2 or relevant qualification.

For more information on the role, contact jporter@sigmar.ie or call 091455305. All applications will be treated with the utmost discretion and care.

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