Wei Ding Email and Phone Number

• Prepare and execute regulatory submission of IVD products, which require interaction with cross-functional teams and international stakeholders, to ensure timely approval of products by global regulatory agencies.• Provide end-to-end strategic and tactical IVD regulatory guidance for new product introductions and existing product changes across the global market, ensure products are brought to market on time, and sustained throughout life cycle.• Manage all aspects of 510(k) submission processes, including product performance validation, documentation, timelines, and communication with regulatory authorities.• Review and approve a variety of regulatory submission-related documents including design control, technical files, product labeling, promotional materials, and change control, etc.• Conduct regulatory risk assessments and develop mitigation strategies for IVD products.• Stay current with evolving regulatory requirements in medical device industry and assesses impact of policy changes on organization business and product development.• Be viewed as a subject matter expert in regulatory aspect of product development, global product commercialization, product manufacturing, product importing and exporting.• Represent organization to develop and maintain relationships with the FDA and other global regulatory agencies.• Responsible for the development, implementation, and rollout of training to the organization on Regulatory Affairs policy and regulatory requirements.• Responsible for interact with CRO, manage, oversight and troubleshoot their clinical studies to ensure optimal execution and compliance.• Drive improvement in the quality system to ensure compliance with all applicable regulations.

• Guide and prepare regulatory submission for approvals or registration of a NGS IVD product in Japan and Europe.• Be expert for broad landscape of regulatory requirements from FDA, PMDA and CE mark across the IVD assay development, such as design control, QMS, device verification and validation, clinical validation, risk management, and post-market surveillance, etc..• Represent technology team to provide strategic input and technical guidance on regulatory submissions in Asia and Europe such as PMDA/MHLW (Japan) and IVDD/IVDR (EU).• Be the author of key technical files for regulatory submission including performance evaluation plan/report, analytical performance plan/report, etc.• Review and approve a variety of dossier documents including device description, intended use, product labeling and packaging, and promotional materials.• Lead cross-functional teams including Quality, Marketing, Manufacturing, Project Management, and Clinical Operations to address questions & requests from regulatory authorities regarding device performance and achieve timely response.• Liaise US team and Japan team in communication with government agencies in Japan, anticipate regulatory obstacles in IVD approval, and develop solutions to mitigate risks.• Support FDA submissions for follow-on CDx claims and product upgrade.• Drive technology transfer to partner labs in Japan and China, ensuring operation readiness in the context of workflow alignment, assay performance, and regulatory compliance with different applications as RUO, LDT, or IVD.

Key Responsibilities • Led the end-to-end development of a biomarker IVD CDx assay, starting from strategic planning, IDE/IRB application, design control program, analytical V&V, software V &V, all the way to PMA submission to FDA. • Successfully developed and validated multiple biomarker assays by implementing diverse technology platforms, such as ELISA, NGS, PCR, and IHC, in a CLIA-licensed and CAP-accredited lab settings.• Hands-on testing of clinical trial patient samples throughout the entire workflow from sample logistics to data analysis and reporting to pharma sponsors in support of their various needs such as biomarker identification, PD, patient inclusion, diagnosis, and prognosis.. • In-depth understanding of GMP, GCLP, GLP, CLIA/CAP and NYS regulation standards and guidelines and their application in lab procedures, document control and sample management. • Responsible for assay data analysis, presentation and document writing including SOPs, protocols, reports, etc.• Executed assay transfer, technical and personnel training, lab inspection, and quality management for both domestic and international partner labs.• Managed and supervised junior team members. • Improved assay performance and sample management by introducing novel methods, materials, automation, or laboratory Information Management System (LIMS).• Conducted root cause analysis and managed product-related issues with CAPA process.• Supported lab and document preparation for audit or inspection from CLIA, FDA, or project sponsors, and provided response to audit findings.• Contributed to matters related to lab workflow, sample management, data management, project budget, regulatory requirements, timeline of deliverables, and business partnership.