Regulatory Affairs Specialist 3
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About The Position
The Regulatory Specialist is responsible for obtaining and synthesizing scientific information related to clinical studies, analytical studies, post-market performance studies and external quality assessment testing and using this published and unpublished information to appropriately update Performance Evaluation Plans (PEP), Performance Evaluation Reports (PER) and post-market performance follow-up (PMPF) documentation determining if the device meets the requirements according to the IVDR. The Regulatory Specialist will create / maintains Summary of Safety and Performance (SSP) and Technical Documentation updates to support IVDR compliance. The incumbent may be assigned to core team related activities, international regulatory submissions, on-market regulatory activities, and responsibility for submissions to the EU Notified Body, as need arise. The Regulatory Specialist is to provide high-quality written deliverables on behalf of the Regulatory Affairs Department following appropriate regulatory guidance and scientific writing standards. This position requires commitment to excellence, and ability to work in a fast-paced, technically skilled, team environment.
