Larry Spears

Larry is the Executive VP of Regulatory Affairs/Quality Assurance for Touchstone Technologies Silicon Valley, Inc. “Knowledge is Power”. He has deep regulatory expertise from over 35 years experience in government and consulting. This includes investigations, compliance and regulatory roles with FDA including senior compliance leadership positions in the CDRH Office of Compliance, as a consultant with a large life sciences consulting firm and as an independent consultant.

Mr. Spears provides global regulatory strategy consultation to Life Science companies primarily in medical devices/diagnostics and pharmaceuticals with a focus on quality systems gap assessments, FDA mock inspections, quality system development and planning, and remediation for FDA inspection findings including, among others, CAPA and complaints, design controls, supplier controls, production management, and training.

In the past few years, while with a Big 4 Consulting firm, he co-authored thought leadership articles on: managing quality systems and compliance, medical device and pharmaceutical off-label promotion, compliance and risk, unique device identification, cloud computing, DEA compliance, and others.