Regulatory Affairs Manager

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360, Guardant360 CDx, Guardant360 TissueNext, Guardant360 Response, and GuardantOMNI tests for advanced stage cancer patients, and Guardant Reveal for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield test, aims to address the needs of individuals eligible for cancer screening.

Job Description

The Regulatory Affairs Manager will provide direct regulatory support for screening products. This role will actively support development and implementation of regulatory strategies, premarket submissions, post-market change submissions, annual reports, labeling review, and other related activities. Responsibilities will include all aspects of product core team support, including planning and implementation of regulatory submission strategies, preparation of submissions, reviewing protocols and reports, and interpreting regulations and requirements.

This position is an individual contributor role with expectations to be hands-on and will liaise closely with regulatory and cross-functional teams at Guardant Health to bring innovative diagnostic assays to market and keep them compliant.

Essential Duties and Responsibilities

• Support screening new product development and support and sustaining teams.
• Effectively prepare regulatory submission documents in adherence with applicable regulations for submission to U.S. government agencies.
• Support regulatory activities throughout product lifecycle and maintain registrations by ensuring regulatory compliance.
• Author, amend, and supplement new or existing submissions, annual reports, Q-submissions, premarket approvals (PMAs), etc.
• Review product related documents (e.g., plans, protocols, reports) and product labeling including marketing materials.
• Facilitate product approvals through effective communications and negotiations with regulatory agencies, and project teams.
• Responsible for managing regulatory project workflow including prioritizing project deliverables and establishing timeframes for projects with cross-functional teams.
• Responsible for overseeing progress and completion of projects with project team members, ensuring timeframes and deadlines are met.
• Lead and coordinate internal tracking, authoring, and review of responses to requests from regulatory agencies.
• Identify project risk and develop alternate strategies or contingency plans as mitigation.
• Provide strategic advice to the cross-functional team in response to their queries, based on regulatory experience and area of expertise.
• Build and maintain a cooperative and respectful working environment. Be available as an internal resource for peers, advising on regulatory issues and strategies.
• Participate in the planning and execution of the regulatory strategic direction for the business.
• Provide updates to project teams and management regarding regulatory status and requirements of company products.

Qualifications

• Bachelor’s or higher degree in life sciences, engineering or related field with at least 7 years work-related professional experience.
• 5+ years experience in a medical device or IVD regulatory affairs role, preferably in molecular diagnostics.
• Experience with PMA, sPMA, 510(k), Q-Submissions, IDE, BDD, and other related regulatory submissions.
• Strong working knowledge of IVD and/or medical device development, design control, change control and cGMP / Quality Systems.
• Demonstrated experience with effectively preparing and coordinating regulatory submissions.
• Successful track record of securing and maintaining product approvals and registrations through application of strong communication and analytical skills.
• Awareness of regulatory issues and challenges associated with diagnostic and/or medical device development.
• Strong analytical skills and attention to detail.
• Excellent communication skills (verbal and written) and ability to convey complex issues in a straightforward manner.
• Outstanding organizational skills to balance activities for multiple projects.
• Self-starter with ability to work independently with minimal supervision.
• Hands-on, action-oriented, and able to negotiate and collaborate effectively.

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