Giselle Zhang has five years of combined RA/QA experience in the medical device industry, primarily focused on U.S. Regulatory Submissions, including 510(k) submissions, FDA Pre-Submission applications, and Regulatory Pathway strategies. Giselle has extensive Quality Assurance experience in supporting manufacturers with preparation for FDA QSR inspections and Quality Management System Implementations. Giselle is also experienced in Risk Management File preparation, Software Validation File preparation, as well as training to Quality Assurance topics.
Giselle Zhang - China
Consultant, Quality and Regulatory Affairs
Giselle Zhang has five years of combined RA/QA experience in the medical device industry, primarily focused on U.S. Regulatory Submissions.
