2.) has more than 10 years of experience in management, quality regulations and intellectual property rights in the medical device industry, rich experience in the operation of international medical device regulations and quality requirements, rich experience in the actual operation from general to first-class enterprises, rich experience in planning, researching, and implementation of regulations and quality, and has participated in many international and domestic mergers and acquisitions and integrations in the medical device industry
3.)Mr. Yang has been involved in the medical device industry from active to passive, reagents and pharmaceuticals, from general to sterile, from low risk to high risk, from small devices to large devices, etc.; he has been responsible for all aspects of the medical device industry from research and development, supply chain and production, to market access, customer complaints, and alert systems
4.)Mr. Yang has more than 10 years of experience in regulatory affairs, and has been responsible for more than 100 global registration projects, and has been responsible for regulatory registration for many years. global registration projects, responsible for regulatory registration business for many years, has the experience of managing a team of hundreds of people, from ordinary engineers to the top management, and maintains close professional contacts with international regulatory organizations/national bureaus/provincial bureaus/municipal bureaus/regulatory experts.
5.) Member of secretariat of Asian Harmonization of Medical Devices Regulations (AHWP) and member of WG1-Pre-Market Submission and CSDT, WG3-Quality Management System; Guangdong Provincial Government Quality Award. Management System); Member of Guangdong Provincial Government Quality Award assessor expert pool and Shenzhen Mayor's Quality Award assessor expert pool; Deputy Secretary General of Shenzhen Medical Devices Industry Association; Member of Shenzhen Market Supervision Administration Expert Committee
6.) Since 2002, she has been the technical manager, regulatory technical manager, quality control department manager of a famous company in China, which is a listed company in New York Stock Exchange. Regulatory Technical Manager, Manager of Quality Management Department, Manager's Representative, Director of Quality Regulations, Executive Director of Quality Committee, Director of Quality Regulations Specialized Committee. Before that, he worked as project manager and development manager in pharmaceutical and medical device group companies (H-share and A-share listed)
7.) He has rich theoretical and practical experience in the fields of strategy, process management, metrics and improvement, knowledge management, customer and market; he has participated in the evaluation of the quality awards of the Guangdong Province and the Shenzhen Municipal Government for a number of times as a quality expert; and has made presentations at various international forums and conferences organized by the competent authorities for many times. He has made keynote presentations at various international forums and conferences organized by competent authorities
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 marketing. 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 Province. ), member of Expert Panel for Guangdong Provincial Government Quality Awar and Shenzhen Mayor Quality Award, and Vice-Chairman of Shenzhen Association for Quality. 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 the whole process from R&D, supplier chain, manufacturing, market clearance, customer complaint
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 the past. 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 Science. Degree of Biomedical Engineering.
7) Vice Secretary of SAMD (Shenzhen Association of Medical Devices)