Alice Ouyang

Alice Ouyang, PhD, RAC, currently serves as the Regulatory Affairs Manager at CIRCA Scientific, focusing on regulatory strategy planning and submissions for both domestic and international contexts. Prior to this role, Alice was the Chief Consultant at Vita Solutions Inc, providing expertise in regulatory and clinical consulting, with significant knowledge in MEDDEV Rev 4, EU MDR, as well as technical writing and FDA submissions. Alice also held the position of Senior Manager Clinical Development Science at Philips, where procedures for clinical evaluation and reporting were established in accordance with regulatory standards. Earlier experience includes working as a Regulatory Scientist at Cook Medical, where Alice prepared clinical evaluations and reports to support global regulatory submissions. Alice earned a Bachelor of Science in Biological/Biosystems Engineering from Cornell University and a PhD in Biomedical/Medical Engineering from Purdue University.