Meet Larry SpearsDirector, Deloitte & Touche LLP |
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Larry Spears, a director with Deloitte & Touche LLP in the Life Sciences Regulatory and Compliance practice, has more than 30 years of experience with the Food and Drug Administration (FDA) as an investigator, compliance officer, and compliance manager.
For the majority of his public sector career, Larry worked in the medical devices area at the FDA, gaining considerable experience in quality systems inspection assessment, recalls, regulatory case management, and compliance and enforcement strategy development. He served as the deputy director for regulatory affairs for eight years, providing daily oversight regarding regulatory, compliance, and enforcement decisions affecting the medical device industry.
A frequent speaker at industry trade association conferences, Larry has addressed topics such as medical device regulatory trends and outlook, warning letters and enforcement actions, quality systems requirements, recalls, import and export regulatory requirements, pre-market submissions, and adverse event reporting. He has also provided training to representatives from counterpart regulatory agencies across the globe on similar topics as a frequent speaker at international conferences sponsored by the FDA’s Center for Devices & Radiological Health.
Larry draws on his significant FDA experience — particularly in the medical devices area — to help clients develop quality and risk strategies; enhance highly regulated processes such as Corrective and Preventive Action (CAPA); and assist with complaint handling and medical device reporting; inspection planning and readiness; and remediation in response to enforcement such as 483s, Warning Letters, and Consent Decrees.
Larry earned a bachelor’s degree in zoology from Arizona State University and completed several master-level courses in administration and management at Central Michigan University.
