Sarah Stec is an associate in the Public Policy Practice in Washington DC. She has experience in assisting life sciences companies, including medical device and pharmaceutical companies, understanding new and evolving regulatory duties, including how those international regulations can work together, as well as providing guidance on international corporate accreditation and regulatory issues. Her unique approach to regulatory issues incorporates a deep understanding in the corresponding legal and quality issues, providing well-rounded solutions to clients in heavily regulated life sciences industries.
Sarah is a member of the Regulatory Affairs Professionals Society (RAPS) and the Food and Drug Law Institute (FDLI). Sarah is a faculty member at FDA to train new hires at FDA-CDRH on FDA regulations, and has extensive experience training industry and international regulators on both the EU and US FDA regulations. She regularly attends and speaks at international medical device and pharmaceutical regulatory conferences. She has a Regulatory Affairs Certification (RAC), covering regulations dealing with medical devices, pharmaceuticals, and biologics in the European Union.