Responsible for the study management of medical device clinical trials, (regulated and non) clinical study design, and clinical strategy. Also qualified in the development and creation of product surveillance plans, clinical evaluation reports and reports to FDA.Responsible for ensuring regulatory requirements within marketing literature and promotional material are met and align with the appropriate 510(k)s, design dossiers, technical files, etc. for various classes of medical devices•Review and approve marketing literature, informational material, surgical techniques, and other items for Global use for internal and external dissemination•Coordinate with International regulatory regarding the dissemination of all international informational material•Research, read, and understand professional journal articles -- particularly orthopedic articles, regulatory documents, engineering reports, test reports and results of clinical studies•Maintain awareness and working knowledge of existing, changed, new and future regulations as they relate to company products, procedures, and informational material.