Yukiko CereghettiHead International RA&C SDIS & Projects at Institut Straumann AG
Regulatory professional with Japanese origin.
Over 10 years’ experience in product registrations in international markets with main focus on Japan.
Worked as Japan product registration expert in orthopedics and dental implant companies such as Stryker, Johnson and Johnson, and Institut Straumann.
Experience of Class I-IV product registration in Japan, FMR, consultation meetings with the PMDA, local premarket clinical trial in Japan, PMDA QMS on-site audit at oversea manufacturer, MDSAP audit, implementation of J-QMS requirements at oversea manufacturer.
Currently Head International RA&C SDIS & Projects at Institut Straumann AG, responsible for product registration and regulatory compliance in Asia Pacific, Latin America, Eastern Europe, Middle East, and Africa.