Description
Summary of Specialized Skills * Design, development and conduct of device based Clinical and Pre-Clinical Research projects. * Experience in writing various clinical documents, including protocols, CERs, reports, research findings. * Design and Implementation of various Pre-clinical trials for pilot studies of various implantable technologies. * Management of scientific/animal studies and clinical projects. * Hands-on experience obtaining Regulatory Approvals for medical devices, CE, PMA, IDE and 510 (k). * Quality assurance ISO and EN and FDA and specialty documentation needs for GMP GLP and GCP compliance. November 206 - Current
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