Josh E.

Medical Device Regulatory Affairs & QMS Implementation Expert

I have a comprehensive background in product development/project management within the confines of international medical device regulations. I thrive on taking vague ideas and ill-defined needs and turning them into concrete reality. I can start a medical device company from the ground up and I can do it on schedule. This includes... From a Regulatory perspective: --Initial regulatory requirements analysis for new markets (EU, Brazil, Australia, US, Canada, etc.) --Identification of applicable test requirements (ISO standards, etc.) and management of test houses --Interfacing with regulatory agencies (FDA Pre-subs) and writing of regulatory submissions such as FDA 510(k)s --Quality System development and implementation to required standards (ISO 13485, FDA, MDSAP, etc.) --Identification of loopholes and temporary workarounds to ease implementation pains and maintain profitability for small startup companies From a Project perspective: --Using good interpersonal skills to keep people motivated and excited --"Conducting the orchestra", developing a logical rhythm of events and ensuring timely completion of tasks --Turning "unknown unknowns" into "known unknowns", forseeing problems before they arise and altering the "orchestra" accordingly --Coordination of teams on an international level --Intelligently focusing energy on tasks with the highest variability, including procurement of additional expertise as necessary --Always keeping an open dialog about the day-to-day changes in the "Good/Fast/Cheap, pick any two but only two of the three" trade-offs in milestone achievement From a Product perspective: --Development of design parameters from organization input (Sales, Marketing, Support, etc.) --Nitty-gritty technical work like engineering drawings/drafting, statistical analysis, resdesigns due to manufacturing constraints, component supplier identification. --Identification, qualification, and day-to-day management of international manufacturers --Design History File/Technical File development and maintenance --Design Transfer for complex electromechanical devices From an Operations perspective: --Part Number/Drawing Number/Revision Control development and implementation --Engineering Change Order workflow and impacts --Purchasing-Manufacturing-Sales-Shipment procedures and throughput --ERP/MRP implementation including workarounds for system limitations I am a strong believer in a person's word. If I tell you I'm going to do something by a certain date that is my word and I'm going to get it done, hell or high-water. I don't mess around: I live on a remote homestead so I grow my own food, build my own structures, fix my own car, brew my own beer. My entire life requires a high level of precision execution every single day, failure is not an option.