I help launch and support Medical Devices and SaMD's in the US, EU, Canada, Australia and ROW. I am currently directing regulatory strategy in the US and other markets for a Class II implantable medical device with Software as Medical Device (SaMD) components. I have experience preparing 510k submissions in the US, MDR/IVDR submissions for the EU, and regulatory submissions to bring medical devices to the market in Canada, Australia, Japan, and some South American countries. My most recent focus has been SaMD and software development compliance with IEC 62304, IEC 62366, and AAMI TIR45:2012. As a leader I have built teams and led teams. As a contributor I enjoy collaborating with people across different departments in an organization and I am passionate about lifting people up and improving processes.
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