Director of Regulatory Affairs, Screening (Early Detection)
Company Description 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. Its Guardant Health Oncology Platform is designed to
leverage its capabilities in technology, clinical development,
regulatory and reimbursement to drive commercial adoption, improve
patient clinical outcomes and 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® and GuardantOMNI® , for advanced
stage cancer patients, which fuel its LUNAR program, which aims to
address the needs of early stage cancer patients with neoadjuvant
and adjuvant treatment selection, cancer survivors with
surveillance, asymptomatic individuals eligible for cancer
screening and individuals at a higher risk for developing cancer
with early detection. Since its launch in 2014, Guardant360® has
been used by more than 7,000 oncologists, over 50 biopharmaceutical
companies and all 27 of the National Comprehensive Cancer Network
Job Description 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 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
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
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
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
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,
Complete other tasks as assigned by the SVP, RA/QA.
Qualifications 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
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
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.
Additional Information 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
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
To learn more about the information collected when you apply for
a position at Guardant Health, Inc. and how it is used, please
review our Privacy Notice for Job Applicants .
Director of Regulatory Affairs, Screening (Early Detection)