Ayse Erkan

Ayse Erkan serves as the Regulatory Team Lead in the medical device industry, where she has accumulated over 15 years of experience combining quality and regulatory roles. After earning a biology degree from Whittier College, she pursued a master's degree in biotechnology at Cal State, initially working in laboratory settings before transitioning to the field to make a more direct impact. Erkan began her career in quality, conducting investigations, and later made a deliberate switch to regulatory affairs, a move she takes pride in despite starting at a lower level to follow her passion. Her specialty lies in new product development, where she provides regulatory input on timelines, compliance standards, and global registrations for products in the US, Canada, and the European Union. As team lead, she coordinates with international regulatory personnel to plan product launches. Erkan is a member of the Regulatory Affairs Professional Society and values her role as a patient advocate, ensuring devices meet high quality standards suitable for her own family. She previously volunteered for three years teaching Turkish to children at a non-profit school serving the Turkish community.