・Supported overseas assignees and locally hired foreign employees relocating to Japan, including visa-related coordination and onboarding support ・Coordinated onboarding processes, compliance documentation, and cross-functional internal approvals in an international environment ・Served as Secretariat of the Diversity & Inclusion Committee for 3 years, supporting internal communication and inclusion-related initiatives ・Contributed to global internal communications and cross-border employee support initiatives

Regulatory Affairs Specialist (Medical Devices – Class I & II) ・Prepared and maintained regulatory documentation for medical devices across Southeast Asia, Eastern Europe, and Latin America ・Coordinated documentation requests and submission support activities with overseas affiliates and distributors across 40+ markets ・Managed Free Sales Certificates, export documentation, and related compliance records for international distribution ・Arranged document legalization procedures, including notarization and authentication through the Ministry of Foreign Affairs and embassies ・Supported foreign manufacturer registration processes and maintained associated regulatory documentation ・Collected, organized, and shared country-specific regulatory information internally to support global market access operations

Managed receipt and distribution of safety information from overseas affiliates and CROs Performed safety database data entry and case processing Assisted in preparation of reports for regulatory authorities Coordinated site notifications related to safety information

Translated medical documents (Japanese-English) Prepared English documentation templates

Managed student recruitment activities and career guidance support Conducted school information sessions and individual consultations

Administrative & Marketing Coordinator (Educational Institution) Managed scheduling and payroll administration for part-time staff Planned and produced promotional materials and internal publications Organized and delivered information sessions and entrance examination briefings Achieved top performance in regional recruitment campaign (451 mock exam registrations) Led event planning and operational coordination Supported internal PC network setup as OA lead

TOEIC

The Institute for International Business Communication

Credential ID: 1640123-0

ISO13485 Internal Auditor Training Course

SGS Japan Inc.

2015

Credential ID: JPT15/3592

ISO 9001:2015 and ISO 13485:2016 Integrated Internal Auditor Training Course

SGS Japan Inc.

2019

Credential ID: JPT19/21414

Medical Device Regulatory Affairs Standard Training Program

EXPARTNER JAPAN Co., Ltd.

2018

FDA Quality System Regulation Course

Qualys Innova

2018