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Guardant Health // rare-cell diagnostics
, Full Time       Posted: Tuesday, March 17, 2020
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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 & 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.

Job Description

The Director ofRegulatory Affairs Manager provides direct regulatory support for the LUNAR diagnostic assay. This role supports development & implementation of regulatory strategy for LUNAR applications in both screening programs & early detection including IDE programs & IVDs. In this role you will support program efforts relative to premarket submissions, FDA interface, regulatory policy & 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 & will liaise closely with the current regulatory & cross-functional teams at Guardant Health to bring innovative diagnostic assays to patients.

Essential Duties & Responsibilities:

  • Ensure early diagnostic regulatory input in early stages & during clinical development to Development Team for the LUNAR product.
  • Oversee regulatory compliance & the action roadmap for activities with the FDA & EU & other regulatory bodies to ensure Guardant Health's interests are reflected.
  • Collaborate closely & 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 & negotiation of plans regarding safety, efficacy, & quality to assure viability for US & other global registrations.
  • Accountable for ensuring that regulatory submissions meet appropriate standards & content requirements.
  • Working with VP, Regulatory Affairs, identify risk areas & develop alternative courses of action including anticipation of regulators responses through scenario planning & 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 & other International Quality Standards as appropriate. This includes, but is not limited to, country specific licenses, the design input, review, out-put & verification, validation, transfer & change control.
  • Provide updates as needed to the VP RA regarding regulatory status & requirements, both U.S. & European, of Company products. This includes the implementation of CE marking to products in accordance with IVDD 98/79/EEC & IVDR.
  • Compile and/or direct the compilation of device master records, technical files, design dossiers, FDA & 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) & regulatory requirements, & compliance to all approved licenses.
  • Responsibility for MDR reporting & 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 & maintain procedures relating to the US & 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 & regulation affairs requirements
  • Familiar with regulatory issues & challenges associated with Drug/Diagnostic co-development & companion diagnostics.
  • Track record in successful FDA & ROW (e.g., EU) premarket submissions & registrations
  • Solid understanding of molecular technologies & the impact on outcomes & diagnostic results
  • Leadership capabilities working across varied cultures, expertise & backgrounds
  • Excellent negotiation skills on various levels of hierarchy
  • Outstanding interpersonal & communication skills for bridging scientific & business participants, for negotiating timelines & for effective collaboration.

Additional Information

Employee may be required to lift routine office supplies & 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.

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 & how it is used, please review ourPrivacy Notice for Job Applicants.


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