Lee Ambolt is a seasoned professional in software documentation and quality assurance within the medical technology and biotechnology sectors. Currently serving as a Software Documentation Consultant at Global IVDR Company and a Senior Quality Consultant at QAdvis, Lee has extensive experience in both compliance with IVDR and FDA regulations and the review and update of software documentation for various medical products. Previous roles include System Architecture Documentation and Specifications for a Swedish Biotech IVDR Company, where responsibilities encompassed compliance within the MedTech regulatory framework, and a Life Science Consultant at SolidX AB, focusing on documentation for cancer detection products. Lee's background also includes significant contributions in medical physics, having worked as a Legitimated Hospital Physicist at Region Skåne and a Clinical Scientist at Leeds Teaching Hospitals NHS Trust.
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