Expert in Medical Device Regulatory Affairs and Clinical Studies, including strategic plans, clinical protocols, and FDA submissions such as IDEs, PMAs and 510(k)s. Completed 12 multi-site clinical studies and obtained FDA release of over 100 products. Strong record of domestic and international regulatory success.
With clinical studies, I developed clinical study plans, recruited investigators, obtained IRB approvals, enforced study compliance, prepared progress reports, and controlled budgets. From a compliance perspective, I implemented programs for Protection of Human Research Subjects, Good Laboratory Practices, cGMP/QSR (ISO 13485:2003), European Medical Device Directive, and Med...
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