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Eric Henry is a Senior Quality Systems and Compliance Advisor in the FDA and Life Sciences practice of King & Spalding. In this role Eric advises King & Spalding clients on a variety of regulatory compliance matters including Quality System establishment and remediation, establishment of quality organizations, audit and inspection management and response, compliance-related due diligence reviews for M&A, training, and serving as expert witness during litigation. Eric is a 30-year industry veteran having led and coached global organizations through a wide variety of quality and compliance challenges. Complementing his leadership experience is an extensive hands-on skillset specializing in QMS process development, software design controls (including regulatory frameworks for cybersecurity and machine learning systems), risk management, and CA/PA.
Eric came to King & Spalding from Philips, where he was the Global Head of the Quality Assurance / Quality Engineering organization for the Diagnostic Imaging Business Group, which included seven business units spanning 14 sites globally. Prior to Philips, Eric led design quality assurance at Medtronic’s Diabetes Business Unit, was responsible for software design controls and general design controls effectiveness for GE Healthcare for all GE businesses worldwide, and had software quality and software design leadership responsibility at Boston Scientific and Hologic.
Prior to entering the medical device industry, Eric led a software quality management and program management office consulting capability in the Washington, DC area and held software design and development leadership roles in a small startup, a mid-size healthcare software company, a large financial services regulator and stock market, and a large retail organization.
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