RAQA Senior Specialist

Company Description Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant® is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn , X (Twitter) and Facebook . Position Summary This role is responsible for leading Regulatory Affairs (RA) and Quality Assurance (QA) activities at Guardant Health Japan (GHJ). As an individual contributor, this position will participate in regulatory submissions and be responsible for quality and safety management across approved products as well as products under development or submission. This position is expected to cover RA and QA responsibilities in a balanced manner. The role will support and drive regulatory strategy, submission activities, regulatory authority interactions, QMS operations, product quality management, and quality and safety oversight for GHJ’s products and pipeline, including oncology in vitro diagnostic devices, in vitro diagnostics, companion diagnostics (CDx), and Software as a Medical Device / medical device software. The main responsibilities include preparation and review of regulatory submission documents, regulatory authority interactions, and maintenance and compliance of the company’s Quality Management System (QMS) in accordance with Japanese regulations, including the PMD Act, and applicable industry standards. In addition to leading RA activities, the role will oversee day-to-day QA operations, quality systems, product quality management, and internal and external coordination related to regulatory and quality matters. Key Responsibilities Regulatory Strategy and Submission Activities Drive regulatory strategy, submission planning, approval activities, and post-approval regulatory maintenance for GHJ’s products and pipeline in Japan Participate in and lead regulatory submission activities related to oncology in vitro diagnostic devices, in vitro diagnostics, companion diagnostics (CDx), and Software as a Medical Device / medical device software Prepare, review, and coordinate regulatory submission documents for approval applications, partial change applications, minor change notifications, notifications, regulatory impact assessments, and responses to regulatory authority inquiries Prepare and coordinate communications with PMDA and MHLW, including consultations, inquiry responses, and communications before, during, and after regulatory submissions Review regulatory submission documents, clinical and performance evaluation data, quality-related documents, labeling, product information, and software-related documentation from both RA and QA perspectives Assess regulatory and quality impacts associated with product changes, manufacturing process changes, specification changes, testing process changes, software changes, and other product lifecycle changes Determine and drive necessary regulatory submissions, notifications, documentation updates, and QMS actions Collaborate with Global RA, QA, Clinical, Medical, Commercial, manufacturing-related teams, and external partners to ensure Japanese regulatory and quality requirements are reflected in submission plans and post-market activities Monitor Japanese regulations, guidance, and industry trends, and assess their impact on GHJ’s products, pipeline, regulatory strategy, and QMS operations Quality Management and QMS Leadership Lead, maintain, and continuously improve the Quality Management System (QMS) in accordance with the PMD Act and applicable Japanese regulatory requirements Oversee key quality processes, including SOP lifecycle management, change control, deviations, non-conformities, complaint handling, and CAPA Ensure quality documents and records are accurate and aligned with approved product information, regulatory submissions, product specifications, product-related documentation, and regulatory expectations Continuously enhance QMS processes in line with business growth, product portfolio expansion, and evolving regulatory requirements Support the development and maintenance of quality documents and records required for regulatory submissions, product changes, and post-market activities Quality Events, Complaints, and CAPA Management Manage end-to-end quality events, including complaint handling, investigation, root cause analysis, corrective and preventive action planning, and closure Lead implementation and tracking of Corrective and Preventive Actions (CAPA) to prevent recurrence and reduce potential quality risks Prepare and maintain investigation reports and ensure timely and appropriate closure of quality events Assess regulatory impact, as needed, for quality events, complaints, CAPA, change controls, and other quality-related matters Coordinate communications with internal stakeholders, external partners, manufacturers, and regulatory authorities, as appropriate Audit and External Quality Activities Act as the primary QA representative for internal audits, external audits, and regulatory inspections Lead audit preparation, documentation readiness, and coordination of audit responses and follow-up actions Collaborate with Global QA teams, including US QA, to ensure alignment with global quality standards Support and drive manufacturing-related quality oversight activities in coordination with relevant internal and external stakeholders Ensure alignment among regulatory submissions, approved product information, quality records, and QMS documents during audits and inspections Product Quality and Change Management Own QA review and approval processes related to product release and quality record management Assess quality and regulatory impacts of product changes, specification changes, manufacturing process changes, testing process changes, software changes, and other lifecycle changes Ensure appropriate documentation