Mona Advani is an accomplished medical device regulatory affairs consultant with more than 25 years of experience in U.S. and international regulatory strategy, clinical development, and regulatory submissions. She has a proven track record of securing regulatory clearances and approvals for medical devices in the United States, European Union, Japan, and Canada. Her expertise includes developing regulatory and clinical strategies that align with product development and commercialization objectives.
Experience
Ms. Advani has extensive experience preparing FDA 510(k) and Investigational Device Exemption (IDE) submissions, leading FDA Pre-Submission interactions, and representing clients at FDA advisory panel meetings and international regulatory discussions. She also advises manufacturers on FDA compliance matters, including responses to Form 483 observations and regulatory enforcement actions.
Throughout her career, she has held leadership positions in regulatory affairs, clinical research, and business development, including Senior Director of Regulatory Affairs and Clinical Research. She has organized international regulatory workshops, presented at Regulatory Affairs Professionals Society (RAPS) conferences, and published articles in Regulatory Focus. She is fluent in written and spoken Japanese.