Kristen Grumet

Kristen Grumet

Senior Vice President of Regulatory Compliance
Greenleaf Health

Kristen Grumet is senior vice president of regulatory compliance at Greenleaf Health and an expert in the field of medical device compliance. She has nine years of experience as an FDA field investigator specializing in medical devices and more than 20 years of quality systems compliance management and consulting experience for the industry. As a member of the FDA’s Design Control Inspection Strategy (DCIS) Team and the FDA’s Pacific Region Design Control Training Cadre, she contributed to the development and implementation of the DCIS questionnaire for medical device inspections and trained companies in the use of the questionnaire. At the FDA, she was a Phase II-certified performance auditor in the area of medical devices and has the distinction of being part of the first cadre of certified medical device investigators in FDA history, conducting numerous inspections of European medical device facilities during her six-year tenure with the FDA foreign inspection cadre.



Plenary – Mock Investigator Interview