I am presently an independent quality and regulatory consultant based in New Zealand with offices located in the United States. I have been working in academics and the life sciences industry since 1992. As President and Founding Partner of Caduceus Medical Development, I have been involved with all aspects of daily quality, regulatory and compliance practices as well as all operational issues and challenges supporting my existing client base. I have a proven track record in administration and management. I am currently a member of several professional societies. Roles and responsibilities are summarized below: Develop regulatory/business strategies;Provide assurance/oversight for regulatory policies/procedures;Provide guidance to cross functional team members on current regulatory environment;Regulatory liaison with government bodies;Author/review of regulatory files;Staff management and mentoring;Internal programme establishment, development and maintenance;Establishing regulatory compliant quality management systems (QMS) to support regulatory accreditations and licensingMonitoring and performance evaluation (programmes and personnel)Liaison to peers and the executive management teamEstablishment and implementation of risk management programsProject managerInternal programme and system review, including but not limited to, training, compliant handling, audit, management review, supplier qualification, operations and process controls, design and development, corrective and preventive actions as well as advertising and promotion)Evaluation of field complaints and reporting to regulatory agencies, where appropriatePersonnel management on a day-to-day basis including but not limited to: financial planning, establish and manage department budgets, project management, mentor personnel, technical and personnel training, advisor, conflict resolution in dealing with personnel issues etc.