
Kam Leung Rac
Kam Leung : To put medical device on the shelf Dr. Kam Leung, RAC has extensive experience in the... | Sweden
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Kam Leung Rac’s Location Sweden
Kam Leung Rac’s Expertise Kam Leung : To put medical device on the shelf Dr. Kam Leung, RAC has extensive experience in the development of pharmaceuticals and medical devices, implementation of quality assurance systems and regulatory affairs, as well as business development. He was on P&G’s first pharmaceutical team, for Didronel. He started his medical device career by building the toxicology lab for Pharmaseal, AHS. The team performed USP Class VI testing and validated the LAL pyrogen test as a FDA study center. As project manager he pioneered the moist (decubitus) wound healing concept by introducing HydraGran and HydraPad. These were followed by the BioThotic (preventive) wheelchair cushion. He led three teams to Baxter Technical Awards: Koala Kair air mattress (with Ongpin Plastics), Pulsatile Antiembolism Pump (with Matsushita Electric Works) and hydrophilic coated Foley catheter (with Union Carbide). He was on the Baxter Quality Award team for Euromedical, Edward and Hyland Divisions. As Director of Business Development he introduced 75 blood collection machines throughout China. His team improved a blood fractionation plant to earn the first Chinese GMP certification. He also helped the SFDA-China to write the Blood Products Collection and Improvement Act 1997. Dr. Leung’s Regulatory Affairs assignments included consent decree for a biopharmaceutical plant, Medical Device Reporting for a TNF injection device, build out of an IVD plant and Class 2 product recall. His 510(k) and PMAS introduced endoscopy scopes and software, Aortic Aneurysm devices, RF ablation systems and bone implants. He reconstituted the proton pump in the Q-10 segment of the mitochondrial membrane (Ph.D., Cornell, 1977) and proved the wobble hypothesis (A-I base pairing, Princeton). He is a certified ISO13485 auditor. Specialties: Introduce new products through all manners of internal and external collaboration. Out-of-the-box thinking and superb project management skills to deliver products on time and under budget. Experienced negotiator with Government, regualtory agencies and testing labs.
Kam Leung Rac’s Current Industry Ami Biomed Eng Usc
Kam
Leung Rac’s Prior Industry
Procter And Gamble
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Baxter Bioscience
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Usc La County Medical Center
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Pharmaseal Division
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Baxter Healthcare
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Nursing Products
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Baxter Respiratory
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Baxter World Trade
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Bioscience
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Storz Endoscopy
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Lifepoint
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Medtronic Vascular
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Rita Medical Systems
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Nobel Biocare Usa
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Nobel Biocare
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Ami Biomed Eng Usc
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Work Experience

Ami Biomed Eng Usc
Regulatory Affairs Mgr
Tue Jan 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat May 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time)
Nobel Biocare
Sr. Ra Specialist
Mon Jan 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Oct 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time)
Nobel Biocare Usa
Sr. Regulatory Affairs Specialist
Sat Apr 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jul 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time)
Rita Medical Systems
Manager Regulatory Affairs
Thu Sep 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Feb 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time)
Medtronic Vascular
Sr. Ra Specialist
Sat Jan 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time)
Medtronic Vascular
Sr. Regulatory Affairs Specialist
Thu Jul 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jul 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)
Lifepoint
Director Of Manufacturing
Mon Sep 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat May 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time)
Storz Endoscopy
Biotech Consultant
Thu Jan 01 1998 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)
Baxter Healthcare
Director Of Buz Development
Sat Jan 01 1994 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jan 01 1998 00:00:00 GMT+0000 (Coordinated Universal Time)
Bioscience
Director Of Business Development
Sat Jan 01 1994 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jan 01 1998 00:00:00 GMT+0000 (Coordinated Universal Time)
Baxter World Trade
Technical Advisor
Wed Jan 01 1992 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 1994 00:00:00 GMT+0000 (Coordinated Universal Time)
Baxter Respiratory
Technical Advisor
Mon Jan 01 1990 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jan 01 1992 00:00:00 GMT+0000 (Coordinated Universal Time)
Baxter Healthcare
Director Business Dev
Sat Jan 01 1983 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jan 01 1998 00:00:00 GMT+0000 (Coordinated Universal Time)
Nursing Products
Pharmaseal Technical Consultant
Sat Jan 01 1983 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 1990 00:00:00 GMT+0000 (Coordinated Universal Time)
Pharmaseal Division
Toxicology Supervisor
Thu Jan 01 1981 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 1983 00:00:00 GMT+0000 (Coordinated Universal Time)
Baxter Bioscience
Director Of Business Development
Tue Jan 01 1980 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jan 01 1998 00:00:00 GMT+0000 (Coordinated Universal Time)
Usc La County Medical Center
Clinical Research Associate
Tue Jan 01 1980 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jan 01 1981 00:00:00 GMT+0000 (Coordinated Universal Time)
Procter And Gamble
Staff Scientist
Sun Jan 01 1978 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jan 01 1980 00:00:00 GMT+0000 (Coordinated Universal Time)