- 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.
- 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 email@example.com or call 091455305. All applications will be treated with the utmost discretion and care.
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