Medical Devices Consulting Services, Interim VP➢ Strategy, Business Development, R&D, Clinical Trials, Global Regulatory Affairs➢ Trained in Electronics Engineering and Biomedical Physics Postgraduate Research➢ 25+ years medical device experience (Engineer, Manager, Director, VP, CTO)➢ Versatile skill-set (Management of large teams: R&D, Regulatory Affairs, Manufacturing)➢ Track record of distilling complicated science to bring novel technologies to market quickly➢ Tenacious problem solver possessing an ability to find elegant and least burdensome solutionsI am an accomplished technical leader; having conceptualized product pipelines and represented several medical device companies in their relationships with customers, distributors, professional societies, suppliers, competitors, government agencies and regulators. I have successfully provided management leadership to cross-functional teams, accepting responsibility, driving action and building relationships of trust with team members.I have a deep knowledge of FDA medical device regulations, guidance and export requirements as well as European, Canadian, Australian, Chinese and Japanese approval processes. I have worked directly with international regulatory agencies to negotiate novel pathways and navigate original applications and amendments/supplements to a successful outcome.Specialties: Research and Development of minimally invasive surgical products, tissue ablation, welding and cutting. Design, execution and analysis of preclinical and clinical studies. Technology assessment, Product pipeline planning. US and EU approvals, CE Mark, PMA, 510(k) submissions, responses, panel meetings, vigilance reporting and product labeling.