Regulatory Affairs
Smith & Nephew Inc
USA
Miss Nidhi Gani is a Regulatory Affairs Specialist with Smith & Nephew, Boston, USA. She brings over four years of Regulatory experience working with leading companies such as Smith & Nephew, Terumo cardiovascular, specializing in Manufacturing set-up and transfers, New Product Development strategies and Remediation for Medical Devices in international markets such asNorth America, EU,Asia Pacific, Latin America.
She is currently leading the manufacturing set-up and transfer from USA to Arthrocare Costa Rica unit acquired by Smith & Nephew. Formerly, she hasbeen the Regulatory Affairs Specialist for Sports Medicine, Pulmonary Cardiovascular and Rehabilitation business divisions.She has also worked with medical device start-ups in formulating their Quality and Regulatory Plans and Strategies.
With an Engineering background in Biotechnology and a Master Degree honors in Regulatory Affairs for Medical Devices, Drugs and Biologics from University of Southern California and Northeastern University, US, she aspires to bring robust Regulatory Startegies to the Healthcare industry.
