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 visitand follow the company onLinkedInX (Twitter)andFacebook.

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 GHJs 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 companys Quality Management System (QMS) in accordance with Japanese regulations including the PMD Act and applicable industry 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 GHJs 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 GHJs 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 regulatory compliance submission or notification assessment and follow-up actions are completed
• Maintain documentation integrity and traceability throughout the product lifecycle
• Support product management from pre-launch through post-market stages from both RA and QA perspectives

Training and Quality Culture

• Provide training and guidance on quality compliance and regulatory requirements to internal employees and external stakeholders including manufacturers and business partners
• Promote internal understanding of RA and QA requirements and support relevant functions in appropriately implementing regulatory and QMS requirements in daily operations
• Foster a strong sustainable and practical quality culture across the organization

Qualifications

Education

• Bachelors degree or higher in science such as chemistry physics biological sciences engineering or a related technical field
• Advanced degree in a business or technical field is preferred

Experience

• Approximately 58 years of experience in Regulatory Affairs and Quality Assurance / QMS in Japan
• Experience in RA and QA activities related to oncology in vitro diagnostic devices in vitro diagnostics companion diagnostics (CDx) Software as a Medical Device / medical device software NGS or precision medicine
• Hands-on experience with PMDA or MHLW consultations inquiry responses approval applications partial change applications minor change notifications and other regulatory submissions or notifications
• Experience assessing regulatory and quality impacts of product changes specification changes manufacturing process changes testing process changes software changes and other product lifecycle changes
• Experience with QMS operations quality document management change control deviations non-conformities complaint handling CAPA and audit support
• Experience serving as a Hinseki / Quality Responsible Person is preferred
• Experience working within a Marketing Authorization Holder quality management environment is strongly preferred
• Experience in oncology NGS or precision medicine is a plus

Technical Expertise

• Strong knowledge of the PMD Act and Japanese regulatory requirements for medical devices and in vitro diagnostics
• Understanding of RA and QA requirements for oncology in vitro diagnostic devices in vitro diagnostics companion diagnostics (CDx) and Software as a Medical Device / medical device software
• Hands-on experience with regulatory submission document preparation and review regulatory impact assessment and responses to regulatory authority inquiries
• Practical experience with QMS operations quality documentation change control deviations non-conformities complaint handling and CAPA
• Experience supporting or leading audit and inspection activities
• Familiarity with ISO 13485 ISO 15189 and ISO 14971 is preferred

Business Skills

• Fluent Japanese and business-level English both written and verbal
• Ability to work independently and drive outcomes with minimal supervision
• Strong attention to detail and high accuracy in documentation and record management
• Effective communication skills with cross-functional teams global stakeholders external partners and senior stakeholders
• Ability to identify issues from both RA and QA perspectives and propose and execute practical solutions

Personal Attributes

• Strong interest and hands-on experience in both Regulatory Affairs and Quality Assurance with the ability to cover a broad RAQA scope
• High ownership and accountability mindset
• Hands-on and execution-focused
• Comfortable operating autonomously in a lean and fast-paced environment
• Able to communicate Japanese regulatory and quality requirements effectively in a global environment and drive alignment with internal and external stakeholders

AI & Digital Fluency

• Demonstrate curiosity sound judgment and the ability to critically evaluate and responsibly leverage AI-enabled tools in accordance with company policies ethical standards and regulatory requirements to improve the efficiency effectiveness and quality of work.

Within the range individual pay is determined by work location and additional factors including but not limited to job-related skills experience and relevant education or training. If you are selected to move forward the recruiting team will provide details specific to the factors above.

Employee may be required to lift routine office supplies and use office of the work is performed in a desk/office environment; however there may be exposure to high noise levels fumes and biohazard material in the laboratory to sit for extended periods of time.

Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities long-term conditions mental health conditions or sincerely held religious beliefs. If you need support please reach out to

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin or protected veteran status and will not be discriminated against on the basis of disability.

All your information will be kept confidential according to EEO guidelines.

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