Director of Regulatory Affairs (IVD) – Lunar (Early Detection)
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform is designed to leverage our capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs.
In pursuit of our goal to manage cancer across all stages of the disease, Guardant Health has launched two liquid biopsy-based tests, Guardant360 and GuardantOMNI, for advanced stage cancer patients, and is developing programs for recurrence and early detection, called Project LUNAR. Since its launch in 2014, Guardant360 has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.
This role works out of our Headquarters in Redwood City, CA. Due to the Covid 19 Pandemic Guardant Health has temporarily classified this role as ‘working from home status’, scheduled to return onsite at HQ when it is determined safe to do so.
The Director of Regulatory Affairs Manager provides direct regulatory support for the LUNAR diagnostic assay. This role supports development and implementation of regulatory strategy for LUNAR applications in both screening programs and early detection including IDE programs and IVDs. In this role you will support program efforts relative to premarket submissions, FDA interface, regulatory policy and practice. Facilitate integration of Dx regulatory strategy for LUNAR applications 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.
Essential Duties and Responsibilities:
- Ensure early diagnostic regulatory input in early stages and during clinical development to Development Team for the LUNAR product.
- 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 and partner with internal as well as external stakeholders.
- 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 Directive/Regulation, 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 and IVDR.
- Compile and/or direct the compilation of device master records, technical files, design dossiers, FDA and European submission documents, and/or any other related documents/reports, ensuring timely submissions to CDRH and/or global regulatory bodies, 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.
- Responsibility for ensuring Post Market surveillance/ vigilance systems, liaising with others in the quality departments, QA/QC.
- Complete other tasks as assigned by the SVP, RA/QA.
- Advanced education degree in life-sciences, engineering or public health with more than 5 years work related professional 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 and regulation affairs requirements
- Familiar with regulatory issues and challenges associated with Drug/Diagnostic co-development and companion diagnostics.
- Track record in successful FDA and ROW (e.g., EU) premarket submissions and registrations
- Solid understanding of molecular technologies and the impact on outcomes and diagnostic results
- Leadership capabilities working across varied cultures, expertise and backgrounds
- Excellent negotiation skills on various levels of hierarchy
- Outstanding interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective collaboration.
Employee may be required to lift routine office supplies and use office equipment. Majority 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 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 and will not be discriminated against on the basis of disability.
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Job posted: 2020-07-10