Ed Woo

Senior Director, Regulatory Affairs APAC at Independent

Speaker, Advisor

Mr. Ed Woo is an independent regulatory consultant since 2024; an accomplished business leader with 25+ years of medical device regulatory experience of Asia Pacific markets. He was the APAC Regulatory Affairs Lead of Philips Asia Pacific 2023, Sr. RA Dir. of Varian, a Siemens Healthineer company 2012 - 2022, leading the Regulatory Affairs function for the Asia Pacific region. Prior to this, he was the Regulatory Affairs Director of Medtronic Cardio-Rhythm Disease Management Business in Minneapolis, USA 2002 - 2012; his main roles included regulatory policy strategy & advocacy in Asia. He was on expatriate assignment to establish the Regulatory Affairs function for Medtronic Asia Pacific 1996 – 2002. He has also held various technical, marketing, and managerial roles in Medtronic. Mr. Woo was a founding member and vice-chairman for the Asia Harmonization Working Party (AHWP, now GHWP). He is currently serving as member of Korea MFDS Global Expert Group, and as advisor to GHWP WG1. He has been a speaker and trainer on Regulatory Affairs topics at conferences & training programs sponsored by AMDC, APACMed, AdvaMed, AHWP, China NMPA, Korea MFDS & RAPS, championing medical device regulation convergence in Asia. Mr. Woo holds an MBA from University of Chicago, M.S. in Biomedical Engineering from Case Western Reserve University, and B.S. in Biomedical Engineering from University of Iowa