Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 & GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence & early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers.
The Dir of Regulatory Affairs provides direct regulatory support for CDx. This role supports development & implementation of regulatory strategy for all CDx applications in both screening programs & early detection including IDE programs, IVD, & companion diagnostics. In this role you will support program efforts relative to premarket submissions, diagnostic partnering with biopharma, FDA interface regulatory policy & practice. Facilitate integration of Dx regulatory strategy at Guardant Health. This role, as an individual contributor, will report to the VP of Regulatory affairs & will liaise closely with the current regulatory & cross-functional teams at Guardant Health to bring innovative diagnostic assays to patients.
- Ensure early diagnostic regulatory input in early stages & during clinical development to Development Team for CDx.
- Oversee regulatory compliance & the action roadmap for activities with the FDA & EU & 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 & 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 & negotiation of plans regarding safety, efficacy, & quality to assure viability for US & other global registrations.
- Accountable for ensuring that regulatory submissions meet appropriate standards & content requirements.
- Working with VP, Regulatory Affairs, identify risk areas & develop alternative courses of action including anticipation of regulators responses through scenario planning & development of contingency plans.
- Ensure compliance with the U.S.A FDA Code of Federal Regulations, the European in Vitro Diagnostic Directives, EN 13485 & other International Quality Standards as appropriate. This includes, but is not limited to, country specific licenses, the design input, review, out-put & verification, validation, transfer & change control.
- Provide updates as needed to the VP RA regarding regulatory status & requirements, both U.S. & 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 & European submission documents, and/or any other relate documents/reports, ensuring timely submissions to CDRH, etc., to meet Company product(s) & regulatory requirements, & compliance to all approved licenses.
- Responsibility for MDR reporting & 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 & maintain procedures relating to the US & International Regulatory requirements.
- Champion the design, development & implementation & then support management, & maintenance of the Company's Quality System to meet the requirements of US FDA (21CFR 820 QSR, 21CFR 600 & 21 CFR 211), EN 13485, ISO 13485, IVDD & all other applicable quality & 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.
- Advanced education degree in life-sciences, engineering or public health with more than 5 years work related profession experience. Or a Bachelor's degree in similar fields with 8 plus years of experience.
- 3+ years experience in drug or diagnostic regulatory affairs.
- 5+ years multi/cross functional experience in regulatory and/or clinical development, preferably in molecular diagnostics
- Knowledge of IVDs or drug development & regulation affairs requirements
- Familiar with regulatory issues & challenges associated with Drug/Diagnostic co-development & companion diagnostics.
- Track record in successful FDA & ROW premarket submissions & registrations
- Solid understanding of molecular technologies & the impact on outcomes & diagnostic results
- Leadership capabilities working across varied cultures, expertise & backgrounds
- Excellent negotiation skills on various levels of hierarchy
- Outstanding interpersonal & communication skills for bridging scientific & business participants, for negotiating timelines & for effective collaboration.
Employee may be required to lift routine office supplies & use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, & biohazard material in the laboratory environment. Ability to sit for extended periods of time.
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 & will not be discriminated against on the basis of disability.
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Please visit our career page at:http://www.guardanthealth.com/jobs