杨龙

2.）拥有超过10年的医疗器械行业的管理、质量法规、知识产权经验，丰富的国际医疗器械法规及质量要求运作经验，具有丰富的从一般企业到一流企业的实际运作经验，丰富的法规和质量策划、研究、推行经验，并多次参与医疗器械行业国际和国内的并购和整合3.)从事的医疗器械领域涵盖从有源到无源以及试剂和药品，从一般到无菌，从低风险到高风险，从小型器械到大型设备等诸多领域；实际负责了从研发、供应链和生产到市场准入、客户投诉和警戒系统等各个环节4.)杨龙先生拥有超过10年的法规经验，运作超过上百个全球注册项目，多年负责法规注册业务，拥有管理上百人团队的经验，从普通工程师做到最高管理层，与国际法规组织/国家局/省局/市局/法规专家保持密切专业联系。5.)亚洲医疗器械法规协调组织（AHWP）秘书处成员（members of secretariat）， 以及AHWP1，3工作组成员（member of WG1-Pre-Market Submission and CSDT, WG3-Quality Management System）；广东省政府质量奖评审员专家库成员及深圳市市长质量奖评审员专家库主任审核员；深圳市医疗器械行业协会副秘书长；深圳市市场监督管理局专家委员会委员6.)从2002年开始，担任国内知名公司（美国纽交所上市公司）的技术法规技术经理、质量管理部经理、管理者代表、质量法规总监、质量委员会执行主任、质量法规专业委员会主任等职。之前曾任医药和医疗器械集团公司（H股和A股上市）项目经理、开发部经理等职7.)在战略、流程管理、度量和改善、知识管理、客户和市场等领域有丰富的理论和实战经验；作为质量专家多次参加广东省和深圳市政府质量奖的评奖；多次在各种国际论坛以及主管当局组织的会议上作主题报告1) Mr. Long Yang has over 10 years of management experience in the medical devices industry. Since 2005, he has worked as QA manager, management representative and Director of QA and RA in Mindray, one of the most famous manufacturer in China and a NYSE listed company; and services as project manager and R&D manager in Livzon Group.2) He also has been acting as member of secretariat and member of WG1&3 in AHWP (part-time), member of Expert Panel for Guangdong Provincial Government Quality Awar and Shenzhen Mayor Quality Award, and Vice-Chairman of Shenzhen Association for Quality.3) He has good experiences in the entire field from active, non-active to IVD and pharmacy, from non-sterile to sterile, from low risk to high risk, from little to large equipment, and in whole process from R&D, supplier chain, manufacturing, market clearance, customer complaint and Vigilance system.4) Been invited as Keynote speaker in many Forum.5) Being the core team member of Merging and Acquisition of Medical Device Company in Global market and China in Mindray. Experienced in Merging and Acquisition of Global and Chinese Medical Industrial.6) Master Degree of Biomedical Engineering.7) Vice Secretary of SAMD(Shenzhen Association of Medical Devices)