Mei-Ru L.

Mei-Ru L. has a diverse work experience in the field of regulatory affairs, primarily focused on the medical devices industry. Mei-Ru currently holds the position of Head of Regulatory Affairs at Intersect ENT, Inc since 2021. Prior to this, they worked at Occlutech as the Director of International Registration from 2019 to 2021, where they led the international registrations and regulatory affairs organization for global approvals and product registrations of class III medical devices worldwide.

Before joining Occlutech, Mei-Ru L. served as a Global Regulatory Affairs Consultant at knoell Germany GmbH from 2018 to 2019. Mei-Ru also has experience working at Dornier MedTech as the Regional Quality Management and Regulatory Affairs Manager for the Asia Pacific region from 2016 to 2018. In this role, they supervised regulatory strategies in 15 countries and managed various responsibilities such as planning, budgeting, and labeling.

Mei-Ru L. started their career at National Taiwan University Hospital as a Research Assistant from 2003 to 2005. Mei-Ru then transitioned into regulatory affairs roles, working for companies like Dentsply Sirona, TaiDoc Technology Corp, Seinoh Optical Co., Ltd, and HMD BioMedical Inc. in various specialist positions.

Overall, Mei-Ru L. has gained extensive experience in regulatory affairs, focusing on international registrations and strategic business development projects. Mei-Ru'sprogressive career trajectory reflects their expertise in managing regulatory strategies, ensuring global compliance, and driving successful product registrations for medical device companies.

Mei-Ru L. completed their Master of Science in Biochemical Engineering at National Chiao Tung University. Mei-Ru has also obtained several certifications related to medical devices and regulatory affairs. Mei-Ru L. is certified in Global Medical Device Regulatory Affairs, Good Distribution Practice for Medical Devices (GDPMDS) Internal Auditor, ISO 13485:2016 Medical Device Management Systems Internal Auditor, ISO 13485:2016 Medical Device Management Systems Lead Auditor - IRCA, and ISO 13485:2016 Quality Management Systems - Management System Manager for Medical Devices. Additionally, they have certifications in Intellectual Property Rights from National Chiao Tung University, Medical Device Regulation (EU 2017/745) and Medical Device Regulation (EU MDR) -Qualified Person (Person responsible for regulatory compliance) from TÜV SüD, Medical Device Single Audit Program (MDSAP) from SGS, and Technical Documentation for Medical Devices to MDR from TÜV SüD.