Full Job 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. 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.
The Senior Regulatory Affairs Specialist will manage activities associated with the approval of Class III in-vitro diagnostic (IVD) medical devices. This individual will also be responsible for assessment of device changes for regulatory implications for CDx and regulatory risk determinations to assess the use of the device in clinical trials.
Support regulatory approval of Next Generation Sequencing (NGS) based IVD medical devices in global markets
Manage Pre-Submission activities to align with FDA on proposals to support PMA/sPMA approvals
Participate in formal CDRH/CDER joint interactions, including teleconference or in-person meetings
Facilitate and prepare a variety of device regulatory submissions aimed at approvals (PMA, CE mark, IDE submission, Annual Reports, Export certificates, etc.)
Assess Significant Risk / Non-Significant Risk / IDE exempt studies for study risk determination
Support complex CDx development projects with multiple pharmaceutical partners from early development to PMA submission
Interact with multifunctional teams, regulatory colleagues and pharmaceutical partners to determine optimal regulatory paths towards development and registration activities
Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects
Provide regulatory support on project teams
Participate in review of labeling changes
Review proposed device changes
Guardant Healths' Headquarters is in Redwood City, CA. This position has the option to work remotely from any location on the West Coast.
BS, MS or PhD in a scientific/engineering discipline. Advanced degree preferred
At least 4 years of experience in the medical device, diagnostics, biopharmaceutical or another life sciences industry
Regulatory experience required, preferably at least 2 years
RAC certification is preferred
CDx and/or IVD device experience strongly preferred
Familiar with FDA, IVDD/IVDR, ICH regulations/guidelines
Demonstrated project management and organizational skills
Excellent writing and verbal communications skills
Self motivated and proactive work style
Ability to work in a fast-paced/entrepreneurial team environment
Employee may be required to lift routine office supplies up to 20 lbs 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.
All your information will be kept confidential according to EEO guidelines.
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Please visit our career page at: http://www.guardanthealth.com/jobs/