J. Girard Griggs
Griggs works with foreign firms, importers and customs brokers to ensure that imported medical devices meet U.S. requirements. When devices are non-compliant, he works with others at the FDA to detain, refuse and sometimes destroy non-compliant shipments so they don’t enter U.S. commerce.
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“The education I received from the Regulatory Affairs and Services program has proven to be essential in providing me with the perspective, knowledge, language and background needed to understand the stakeholders as I work in the role of the regulator,” he said. “The program has enabled me to more efficiently examine and determine the impact of the complex issues I am confronted with on a daily basis in the FDA office of compliance and be better prepared to meet our agency’s goal of protecting the public health of the citizens of the United States.”
Griggs developed his interest in working for the FDA’s Center for Devices and Radiological Health (CDRH) while studying in the regulatory affairs and services graduate program. He had two paid summer internships with the FDA while a St. Cloud State student.
“During my first internship I was appointed to the FDA Office of Compliance Bioresearch Monitoring group, where I worked on projects related to the regulation of significant-risk clinical studies,” he said.
Griggs then interned in the Office of Surveillance and Biometrics where he was exposed to the activities surrounding one of the largest medical device recall initiatives in the history of the FDA and also worked on the early development of what is now known as the Unique Device Identification (UDI) program.
“St. Cloud State’s remote access to classes allowed me to continue my coursework while living in Washington D.C.,” he said. “After completing my culminating project with ev3 (now Medtronic), I accepted a position with FDA CDRH Division of International Compliance and Operations Importation Branch in Washington D.C.”
