RAQA Senior Specialist

The RAQA Senior Specialist leads Regulatory Affairs and Quality Assurance activities for Guardant Health Japan, managing regulatory submissions, quality management systems, and product lifecycle oversight for oncology diagnostics and medical device software. This individual contributor role ensures compliance with Japanese regulations, including the PMD Act, while coordinating with global teams and external partners to maintain product quality and safety. The position involves driving regulatory strategy, handling quality events, and supporting audits to align with both local and international standards.