Yukiko CereghettiSenior Regulatory Project Manager 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 Senior Regulatory Project Manager at Institut Straumann AG, responsible for the coordination, monitoring and reporting of product registrations in all markets, and LEAN based continuous improvement programs within regulatory department.