基本資料
深圳市龍德生物科技有限公司首席運營官
姓 名 楊龍
民 族 漢
出生日期 1976年04月
職業(yè)生涯
2.）擁有超過10年的醫(yī)療器械行業(yè)的管理、質(zhì)量法規(guī)、知識產(chǎn)權(quán)經(jīng)驗，豐富的國際醫(yī)療器械法規(guī)及質(zhì)量要求運作經(jīng)驗，具有豐富的從一般企業(yè)到一流企業(yè)的實際運作經(jīng)驗，豐富的法規(guī)和質(zhì)量策劃、研究、推行經(jīng)驗，并多次參與醫(yī)療器械行業(yè)國際和國內(nèi)的并購和整合
3.)從事的醫(yī)療器械領(lǐng)域涵蓋從有源到無源以及試劑和藥品，從一般到無菌，從低風(fēng)險到高風(fēng)險，從小型器械到大型設(shè)備等諸多領(lǐng)域；實際負責(zé)了從研發(fā)、供應(yīng)鏈和生產(chǎn)到市場準(zhǔn)入、客戶投訴和警戒系統(tǒng)等各個環(huán)節(jié)
4.)楊龍先生擁有超過10年的法規(guī)經(jīng)驗，運作超過上百個全球注冊項目，多年負責(zé)法規(guī)注冊業(yè)務(wù)，擁有管理上百人團隊的經(jīng)驗，從普通工程師做到最高管理層，與國際法規(guī)組織/國家局/省局/市局/法規(guī)專家保持密切專業(yè)聯(lián)系。
5.)亞洲醫(yī)療器械法規(guī)協(xié)調(diào)組織（AHWP）秘書處成員（members of secretariat）， 以及AHWP1，3工作組成員（member of WG1-Pre-Market Submission and CSDT, WG3-Quality Management System）；廣東省政府質(zhì)量獎評審員專家?guī)斐蓡T及深圳市市長質(zhì)量獎評審員專家?guī)熘魅螌徍藛T；深圳市醫(yī)療器械行業(yè)協(xié)會副秘書長；深圳市市場監(jiān)督管理局專家委員會委員
6.)從2002年開始，擔(dān)任國內(nèi)知名公司（美國紐交所上市公司）的技術(shù)法規(guī)技術(shù)經(jīng)理、質(zhì)量管理部經(jīng)理、管理者代表、質(zhì)量法規(guī)總監(jiān)、質(zhì)量委員會執(zhí)行主任、質(zhì)量法規(guī)專業(yè)委員會主任等職。之前曾任醫(yī)藥和醫(yī)療器械集團公司（H股和A股上市）項目經(jīng)理、開發(fā)部經(jīng)理等職
7.)在戰(zhàn)略、流程管理、度量和改善、知識管理、客戶和市場等領(lǐng)域有豐富的理論和實戰(zhàn)經(jīng)驗；作為質(zhì)量專家多次參加廣東省和深圳市政府質(zhì)量獎的評獎；多次在各種國際論壇以及主管當(dāng)局組織的會議上作主題報告
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)
