Company Description|Job Description
Guardant Health is a pioneer in non-invasive cancer diagnostics & the first company tocommercialize a comprehensive genomic liquid biopsy. Our proprietary digital sequencing technology is transforming cancer treatment by providing an accurate & precise picture of the individual genomic alterations that cause tumors to grow, change, & develop resistance to treatment. We have combined decades of scientific research, advances in laboratory technology, & our breakthrough innovation in liquid biopsy to create new tests that have already handled tens of thousands of samples. We believe our tests can accelerate new drug development & improve the lives of all patients fighting cancer. Our current products are just the beginning of what we hope to accomplish & new uses of our platform are emerging.
We succeed best by coordinating our creative talents & energies to achieve results far beyond what any single individual could accomplish. We seek very talented people who want to be part of our fantastic team.
The Regulatory Affairs Director provides direct regulatory support for multiple diagnostic projects, including implementation of the FDA QSR & ISO13485 compliant quality management system. Supports development & implementation of regulatory strategy for both companion diagnostics & standalone diagnostics. Support program efforts relative to premarket submission, diagnostic partnering, FDA interface regulatory policy & practice. Facilitate integration of Dx regulatory strategy at Guardant Health. Self directed position with limited oversight for most assignments.
Essential Duties & Responsibilities:
- Ensure early diagnostic regulatory input in early stages & during clinical development to Development Team
- Implement the Regulatory Affairs vision for regulatory compliance & the action roadmap for activities with the FDA & EU & other regulatory bodies to ensure Guardant Health's interests are reflected
- Collaborate closely with pharma partner regulatory affairs for all companion diagnostic programs
- Provide input for all Pharma Business Development activities with respect to the regulatory risks & benefits of potential deals
- 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 Directives, 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
- Compile and/or direct 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
- Ensure employees understand & comply with the requirements of cGMP as applied to the Company's product(s). Provide related training & support to departments as needed
- 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
- Champion the design, development & implementation & then support management, & maintenance of the Company's Quality System to meet the requirements of US FDA (21CFR 820 QSR, 21CFR 600 & 21 CFR 211), EN 13485, ISO 13485, IVDD & all other applicable quality & regulatory standards
- Responsibility for ensuring Post Market surveillance/ vigilance systems, liaising with others in the quality departments, QA/QC
- Continues to expand his/her knowledge base of laws, regulations & guidelines governing the development, licensure & marketing of Guardant products
- Complete other tasks as assigned by the SVP, RA/QA
- Advanced education degree in life-sciences, engineering or public health
- 8+ years work related profession experience
- 3+ years experience in drug or diagnostic regulatory affairs
- 5+ years multi/cross functional leadership 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 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
- Must have excellent customer-service orientation, high degree of professionalism, & work with limited direction
- Outstanding interpersonal & communication skills for bridging scientific & business participants, for negotiating timelines & for effective collaboration.
You have strong knowledge & experience addressing a broad range of accounting matters, ensuring it is processed in compliance with established internal controls. You possess analytical skills needed to correctly grasp & communicate data, & analyze & reconcile accounts; ability to handle confidential & sensitive information with the appropriate discretion; & handle multiple deadlines.
You are a self-starter, work well as a team player, but can work independently when appropriate. You possess the ability to analyze problems & actively strategize to resolve them, pay attention to detail, & have excellent organization & communication skills. You are results oriented. You can juggle multiple tasks, work cross-functionally & at all levels of the organization, whether internally or externally. You are flexible & comfortable in a dynamic, fast-paced environment & can prioritize to focus on the important, not just the urgent.