Michael Leigh

WORK HISTORY

EDUCATION

SKILLS

ABOUT MICHAEL LEIGH

I am a Regulatory/Quality professional with experience in the medical device industry. I bring a comprehensive knowledge of regulatory affairs, compliance, quality systems, Six Sigma tools and techniques, and operations management. Getting the right clearances faster than the competition is my strength. My experience includes a wide variety of Class I and II medical devices and production processes. I have a reputation for providing effective leadership of international pre- and post-market regulatory affairs functions, including registration, premarket clearances, inspections, risk management, auditing, complaint handling, and adverse event reporting. One of my primary goals is to continuously develop my team so that they are valued in the organization with successful career paths of their own. I am committed to building company quality systems to support the business plan. The business\' processes should provide competitive advantage, not be a burden. Most importantly, I help the pieces fit together so that success is measurable and predictable. My career began as a commissioned officer in the United States Air Force. Since that time I have gravitated to positions that allow me to work with the rest of the management team establishing clear goals for the company, plans to achieve them, and successful execution.Specialties: Regulatory affairs and quality systems for medical device companies: premarket submissions, postmarket surveillance, inspections, adverse events, complaint handling, corrective actions, process improvement, auditing, risk analysis, test planning, statistical analysis, calibration systems, regulatory and standards compliance