Eimile Oakes

Medical Writing Manager at GLOBAL Regulatory Writing and Consulting

Speaker

Eimile Oakes, Ph.D., is a medical writing manager with a focus on EU Medical Device Regulation (MDR). At GLOBAL Regulatory Writing and Consulting, she leads a dedicated US-based team that specializes in the preparation of key regulatory documents, including Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up (PMCF) Reports, and Periodic Safety Update Reports (PSURs). Eimile is committed to ensuring that the documentation produced by her team is both thorough and compliant with regulatory standards. Currently, Eimile is engaged in ongoing work with Global Exponential Technologies (GxT), contributing to the development of software solutions that aim to enhance the efficiency of regulatory documentation processes. Her collaborative approach and focus on continuous improvement reflect her dedication to advancing the field of medical device regulation.