Chief Compliance Officer
Tom Banigan is responsible for executive management of corporate quality assurance, regulatory and legal affairs. He has 30 years of experience in quality assurance and regulatory compliance in silicones at NuSil, where he oversees all quality, regulatory and legal functions and is the primary contact with USFDA and international regulatory authorities regarding product submission support.
Tom has led the establishment of all the quality and regulatory systems in support of NuSil’s long-term implantable silicone business, including ISO 9001 certification and 21 CFR Part 820 Medical Device cGMP compliance.
During the course of his tenure, Tom has led the regulatory integration of several Type II drug Simethicone business acquisitions from two multinational silicone manufacturers. As part of this implementation, Tom oversaw the incorporation of 21 CFR Part 210 and 211 (Pharmaceutical cGMP) into the NuSil Quality System™ to address opportunities in support of NuSil’s API business and combination product development initiatives.
Tom serves as a delegate to several international medical device standards committees and has authored or submitted over 700 MAFs and DMFs on behalf of the company.
Tom earned a Bachelor of Science degree in Behavioral Physiology from the University of California, Santa Barbara and a Masters of Business Administration from Pepperdine University. He holds certificates in Hazardous Materials Management and Air Quality Management from the University of California, Santa Barbara.