Company Description|Job Description
At Guardant Health our mission is to conquer cancer with data; as such software sits at the core of everything we do. While we're best known for our molecular diagnostics, which unlock the genomic signatures of cancer, these tests are just the first step in the equation. Turning this genomic data into actionable insights shared with thousands of patients, physicians, & researchers in a scalable, reliable, & secure fashion is a software product challenge.
We wanted flying cars & instead we got 140 characters” is a much-repeated complaint about Silicon Valley. But with all due respect to flying cars, we believe that our mission is even more critical. We've raised more than $500M from some of the leading venture firms in the world to work on this problem.
The Senior Manager/Associate Director Regulatory Affairs provides regulatory support for multiple diagnostic projects. Supports development & implementation of regulatory strategy for IVDs, including companion diagnostics. Support program efforts relative to premarket submission, diagnostic partnering, FDA interactions & post market regulatory support.
Essential Duties & Responsibilities:
- Ensures early diagnostic regulatory input in early stages & during clinical development to Development Team
- Responsible for generating & delivering documentation for life cycle management and/or registration of products through IDEs, 510(k)s, PMAs, supplements, & technical files for CE marking
- Provides study risk determination for assigned projects within Pharma Business Development activities & potential companion diagnostic projects
- Actively review & edit documents associated with product development activities
- Recognizes potential problems, including situations that include ambiguity, by actively reviewing & analyzing internal & external factors
- Assessment of product changes to capture any impact to existing or in-process product registrations & letters to file
- Accountable for ensuring that regulatory submissions meet appropriate standards & content requirements
- Working with Director, Regulatory Affairs, identify risk areas & develop alternative courses of action & development of contingency plans
- Compiles and/or directs the compilation of device master records, technical files, design dossiers, FDA & European submission documents, and/or any other relate documents/reports, ensuring timely submissions to CDRH, etc., to meet Company product(s) & regulatory requirements, & compliance to all approved licenses.
- Monitors worldwide laws & regulations through websites & publications, & identifies & communicates items needed for interpretation for impact to products.
- Assessment of MDR & adverse events for potential regulatory reportabilities. Provide regulatory support as required in the evaluation of customer complaints, ensuring complaint reports meet regulatory requirements.
- Responsibility for ensuring Post Market surveillance/ vigilance systems, liaising with others in the quality departments, QA/QC
- Write & maintain procedures relating to the US & International Regulatory requirements
- Advanced education degree in life-sciences, engineering or public health.
- 6+ years work related profession experience.
- 4+ years experience in drug or diagnostic regulatory affairs.
- 4+ years multi/cross functional leadership experience in regulatory and/or clinical development, preferably in molecular diagnostics
- Experience with IVDs, campanion diagnostics or drug development regulatory requirements
- Track record in successful FDA & global 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
- Ability to multi-task & shift priorities quickly while working under tight deadlines.
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.
We would like to talk with you about our exciting projects we currently have ongoing. Please see guardanthealth.com/jobs for more information & to apply.