Pursuing bachelor's in biomedical engineering from the University of Utah. Experience in medical device design, verification and validation under FDA quality system regulations. Entrepreneurially minded with interest in innovation in medical technology. Focus on regulatory affairs including premarket submissions for medical devices, pharmaceuticals/drugs, biologics, tissue engineered, and combination products for the FDA and global regulatory agencies. Experience with post-market quality and regulatory compliance activities for pharmaceuticals. Technical writing skills for controlled documentation in electronic documentation management system. Laboratory bench skills such as PCR, buffer preparation, cell culture, sequencing, and gel electrophoresis.