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Senior Regulatory Affairs Specialist

Company: Guardanthealth
Location: Redwood City
Posted on: September 16, 2020

Job Description:

Senior Regulatory Affairs Specialist, Companion Diagnostics (CDx) Full-time

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. 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.

Job Description The Senior Regulatory Affairs Specialist, Companion Diagnostics (CDx) 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.

Essential Functions:

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.)

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

Qualifications 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

Additional Information 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.

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 .

Please visit our career page at:  http://www.guardanthealth.com/jobs/

Senior Regulatory Affairs Specialist, Companion Diagnostics (CDx)

Keywords: Guardanthealth, Redwood City , Senior Regulatory Affairs Specialist, Other , Redwood City, California

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