The Regulatory Affairs Director provides direct regulatory support for multiple diagnostic projects, including implementation of the FDA QSR and ISO13485 compliant quality management system. Supports development and implementation of regulatory strategy for both companion diagnostics and standalone diagnostics. Support program efforts relative to premarket submission, diagnostic partnering, FDA interface regulatory policy and practice. Facilitate integration of Dx regulatory strategy at Guardant Health. Self directed position with limited oversight for most assignments.
Essential Duties and Responsibilities:
Ensure early diagnostic regulatory input in early stages and during clinical development to Development Team
Implement the Regulatory Affairs vision for regulatory compliance and the action roadmap for activities with the FDA and EU and 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 and 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 and negotiation of plans regarding safety, efficacy, and quality to assure viability for US and other global registrations
Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements
Working with VP, Regulatory Affairs, identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans
Ensure compliance with the U.S.A FDA Code of Federal Regulations, the European in Vitro Diagnostic Directives, EN 13485 and other International Quality Standards as appropriate. This includes, but is not limited to, country specific licenses, the design input, review, out-put and verification, validation, transfer and change control
Provide updates as needed to the VP RA regarding regulatory status and requirements, both U.S. and 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 and European submission documents, and/or any other relate documents/reports, ensuring timely submissions to CDRH, etc., to meet Company product(s) and regulatory requirements, and compliance to all approved licenses
Ensure employees understand and comply with the requirements of cGMP as applied to the Company’s product(s). Provide related training and support to departments as needed
Responsibility for MDR reporting and 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 and maintain procedures relating to the US and International Regulatory requirements
Champion the design, development and implementation and then support management, and maintenance of the Company’s Quality System to meet the requirements of US FDA (21CFR 820 QSR, 21CFR 600 and 21 CFR 211), EN 13485, ISO 13485, IVDD and all other applicable quality and 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 and guidelines governing the development, licensure and marketing of Guardant products
Complete other tasks as assigned by the SVP, RA/QA
Advanced education degree in life-sciences, engineering or public health
Greater than 5 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 and regulation affairs requirements
Familiar with regulatory issues and challenges associated with Drug/Diagnostic co-development and companion diagnostics
Track record in successful FDA and ROW premarket submissions and registrations
Solid understanding of molecular technologies and the impact on outcomes and diagnostic results
Leadership capabilities working across varied cultures, expertise and backgrounds
Excellent negotiation skills on various levels of hierarchy
Ability to multi-task and shift priorities quickly while working under tight deadlines
Must have excellent customer-service orientation, high degree of professionalism, and work with limited direction
Outstanding interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective collaboration
You have strong knowledge and 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 and communicate data, and analyze and reconcile accounts; ability to handle confidential and sensitive information with the appropriate discretion; and 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 and actively strategize to resolve them, pay attention to detail, and have excellent organization and communication skills. You are results oriented. You can juggle multiple tasks, work cross-functionally and at all levels of the organization, whether internally or externally. You are flexible and comfortable in a dynamic, fast-paced environment and can prioritize to focus on the important, not just the urgent.
Internal Number: REF371Q
About Guardant Health
Guardant Health is a pioneer in non-invasive cancer diagnostics and the first company to commercialize a comprehensive genomic liquid biopsy. Our proprietary digital sequencing technology is transforming cancer treatment by providing an accurate and precise picture of the individual genomic alterations that cause tumors to grow, change, and develop resistance to treatment. We have combined decades of scientific research, advances in laboratory technology, and 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 and improve the lives of all patients fighting cancer. Our current products are just the beginning of what we hope to accomplish and new uses of our platform are emerging.
We succeed best by coordinating our creative talents and 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.