Janet Pulver, MS, CMQ/OE, CSSGB, CQA, RAC, CTBS
Medical Device Senior Operations Officer
FDA, Office of Medical Device and Radiological Health Operations
Janet Pulver is a Medical Device Senior Operations Officer with the FDA’s Office of Regulatory Affairs and serves as national expert in the Medical Device and Radiological Health program areas. Mrs. Pulver joined the FDA in 2008 and has since conducted more than 200 medical device inspections (domestic and international), including inspections covering Human Tissue and Radiological Health regulations. She came to the FDA with more than 10 years of experience in FDA-regulated industry, working in quality and regulatory positions in clinical research, tissue banking and medical devices. Prior to that, she spent eight years as a Chemistry Medical Technologist working with IVDs.
Mrs. Pulver holds Certifications from ASQ (Certified Manager of Quality and Organizational Excellence, Certified Quality Auditor and Certified Six Sigma Green Belt), RAPS (Regulatory Affairs Certification), and AATB (Certified Tissue Bank Specialist). She is also an instructor and content advisor for the FDA’s national Medical Device courses.
Mrs. Pulver earned a Bachelor of Science from the University of Puerto Rico and a Master of Science in Administration from Central Michigan University.
