/ http://www.slideshare.net/images/logo.gif / 際際滷Share feed for 際際滷shows by User: jschwoebel https://cdn.slidesharecdn.com/profile-photo-jschwoebel-48x48.jpg?cb=1522808602 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... http://www.schwoebel.ws/Certifications/Certification.pdf