Dedicated and loyal multi-skilled professional with a good work ethic. Bridges the gap between technical, clinical and sales and marketing fields. Understanding of regulatory matters and tasked with regulatory submissions.Creation of technical files to comply with EN ISO 13485:2012.Head of clinical training including leading on international clinical studies and Key Opinion Leader managementRegulatory submissions including generation of technical files, achievement of 4 product FDA clearances and 2 product CE medical marks. Also dealt with submissions for ANVISA, KFDA & CFDA amongst others.Quality (QMS) management including annual notified body and regulatory audits.Medical Device Risk managementSpecialties: Clinical training, Capital equipment, Sales and marketing,Technical writing, Product development