Job Description
The Dir of Regulatory Affairs provides direct regulatory support for CDx. This role supports development and implementation of regulatory strategy for all CDx applications in both screening programs and early detection including IDE programs, IVD, and companion diagnostics. In this role you will support program efforts relative to premarket submissions, diagnostic partnering with biopharma, FDA interface regulatory policy and practice. Facilitate integration of Dx regulatory strategy at Guardant Health. This role, as an individual contributor, will report to the VP of Regulatory affairs and will liaise closely with the current regulatory and cross-functional teams at Guardant Health to bring innovative diagnostic assays to patients.
- Ensure early diagnostic regulatory input in early stages and during clinical development to Development Team for CDx.
- Oversee regulatory compliance and the action roadmap for activities with the FDA and EU and other regulatory bodies to ensure Guardant Health’s interests are reflected.
- Collaborate closely with pharma partner regulatory affairs for all companion diagnostic programs.
- Provide input for all Business Development activities with respect to the regulatory risks and benefits of potential deals.
- Provide training for key stakeholders
- Represent the regulatory function with objective advocacy of the projects pipeline potential as well as the overall regulatory perspective in diagnostic regulatory requirements
- Ensure alignment of regulatory strategy to business strategy across all functional areas
- Manage development and negotiation of plans regarding safety, efficacy, and quality to assure viability for US and other global registrations.
- Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements.
- Working with VP, Regulatory Affairs, identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.
- Ensure compliance with the U.S.A FDA Code of Federal Regulations, the European in Vitro Diagnostic Directives, EN 13485 and other International Quality Standards as appropriate. This includes, but is not limited to, country specific licenses, the design input, review, out-put and verification, validation, transfer and change control.
- Provide updates as needed to the VP RA regarding regulatory status and requirements, both U.S. and European, of Company products. This includes the implementation of CE marking to products in accordance with IVDD 98/79/EEC.
- Compile and/or direct the compilation of device master records, technical files, design dossiers, FDA and European submission documents, and/or any other relate documents/reports, ensuring timely submissions to CDRH, etc., to meet Company product(s) and regulatory requirements, and compliance to all approved licenses.
- Responsibility for MDR reporting and assessments of adverse event reports to determine if reportable. Provide regulatory support as required in the evaluation of customer complaints, ensuring complaint reports meet regulatory requirements.
- Write and maintain procedures relating to the US and International Regulatory requirements.
- Champion the design, development and implementation and then support management, and maintenance of the Company’s Quality System to meet the requirements of US FDA (21CFR 820 QSR, 21CFR 600 and 21 CFR 211), EN 13485, ISO 13485, IVDD and all other applicable quality and regulatory standards.
- Responsibility for ensuring Post Market surveillance/ vigilance systems, liaising with others in the quality departments, QA/QC.
- Complete other tasks as assigned by the VP, RA.