Quality, Regulatory and Pilot Production,
Grant brings more than twenty years’ experience with start-up, early stage and established companies developing a wide variety of medical devices, including implantable devices from concept through regulatory approval and into post-market surveillance. He has directed Operations, Research & Development, Quality Assurance, Regulatory Affairs, and Clinical Research functions for manufacturers of Class II and III medical devices; and developed global regulatory and clinical strategies. Grant has led regulatory submissions including IDE, PMA, 510(k), Certificates for Foreign Government, and product Technical Files for CE Marking as well as being a corporate liaison with regulatory agencies including FDA and European Notified Bodies. In his role at Sparton Aubrey, Grant leads the Quality Assurance team, as well as providing both Quality and Regulatory consultation for our clients. Grant holds degrees in Electrical Engineering and Computer Science from the University of Sydney.