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. The Guardant Health Oncology Platform is designed to leverage our capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & 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 & GuardantOMNI, for advanced stage cancer patients, & is developing programs for recurrence & early detection, called Project LUNAR. Since its launch in 2014, Guardant360 has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers.
As a Regulatory Affairs Specialist, you will be responsible for activities which lead to & maintain regulatory approvals for In Vitro Diagnostic (IVD) devices. In addition, you will be responsible for assessment of device changes for regulatory implications for companion diagnostics & for regulatory risk determinations to assess the use of the device in clinical trials.
Assist in activities associated with regulatory approval of in vitro diagnostic medical devices in global markets.
Assist in pre-submission activities to gain FDA's feedback on study designs & other proposals
Assist in submission activities for a variety of device regulatory approvals including the US Premarket approvals (PMAs), CE mark, IDE submission, Annual Reports, Export certificates, etc.
Acquire & maintain current knowledge of applicable regulatory requirements & scientific/technical issues in the geographic & discipline as relevant to assigned projects.
May assist in review of labeling changes.
May assist as the internal regulatory consultant for on-market product issues.
May assist in review of proposed device changes.
B.S./B.A. in a science, engineering, or related technical field.
2 years' experience in an FDA regulated industry, or equivalent is preferred.
Experience working in a cross-functional team setting is preferred.
Knowledge, Skills & Abilities:
Strong organizational skills & attention to detail required.
Experience with Microsoft based applications & general knowledge of PC functions necessary.
Ability to work in a fast-paced/entrepreneurial team environment.
Results & goal oriented.
Employee may be required to lift routine office supplies up to 20 lbs & 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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