Nikisha Harwani is a Regulatory Affairs professional with experience supporting medical device and in vitro diagnostic (IVD) products throughout the product lifecycle. Her experience spans regulatory strategy, FDA and global regulatory submissions, clinical trial support, and post-market activities. She enjoys collaborating with cross-functional teams to develop practical regulatory solutions that support compliant product development to bring innovative healthcare technologies to market. She holds a Master of Science in Biomedical Regulatory Affairs from the University of Washington and a Bachelor of Homoeopathic Medicine and Surgery from Maharashtra University of Health Sciences, India.