Sr. Regulatory Affairs Specialist (Oncology Diagnostics)
About The Position
Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn , X (Twitter) and Facebook . Position Summary: Senior Regulatory Affairs Specialist will serve as a regulatory lead to develop and execute global regulatory strategies to support registration, approvals, and lifecycle compliance of assigned In Vitro Diagnostics (IVD) and Companion Diagnostics (CDx) products. This role partners closely with cross-functional stakeholders to drive regulatory deliverables across development and commercialization, including preparation of global submissions, review of protocols/reports, and interpretation of applicable regulations and standards. Preferred technical background includes PCR and/or NGS-based IVD assays. This position reports to the Manager, Regulatory Affairs and will liaise closely with cross-functional teams at Guardant Health to bring innovative diagnostic assays to patients.
Requirements
- Advanced degree in life sciences/engineering/law/public health with 2+ years relevant experience, or Bachelor’s with 4+ years experience.
- 3+ years cross-functional experience in regulatory and/or clinical development, preferably in molecular diagnostics.
- Strong working knowledge of IVD/CDx and/or medical device development processes, including design control, change control, and Quality Systems.
- Demonstrated experience preparing technical documentation for global submissions and maintaining product registrations across lifecycle.
- Proven ability to independently manage the preparation and coordination of premarket and post-market regulatory submissions.
- Successful track record of securing and maintaining product approvals and registrations through effective cross-functional coordination and strategic problem solving.
- Excellent analytical skills with high attention to detail.
- Strong written and verbal communication skills with the ability to convey complex issues in a straightforward manner.
- Highly organized and capable of managing multiple priorities across complex projects in a fast-paced environment.
- Self-motivated and able to work independently and collaboratively with minimal supervision.
Nice To Haves
- EU- IVDR experience a plus.
- Prior experience interacting with a major regulatory agency preferred.
- Proficient with Microsoft Office, Propel, JIRA, Teams, Confluence, and AI tools is a plus.
Responsibilities
- Lead and manage regulatory strategy and project workflow, including prioritization, timelines, and submission readiness for global filings.
- Represent regulatory affairs in cross-functional project teams to support both new product development and on-market product support efforts.
- Responsible for managing regulatory workflow, including prioritizing project deliverables and establishing timeframes, for projects with cross-functional teams.
- Prepare high-quality regulatory submission documents in compliance with applicable regulations, directives, standards, and guidance.
- Drive product approvals/registrations through effective communication with health authorities; lead internal authoring/review of responses to health authority questions.
- Provide regulatory leadership across the product lifecycle, including postmarket activities, complaints inputs, reporting assessments, and audit/inspection readiness.
- Collaborate with program management, product development, quality, operations, and external partners to align strategy, identify regulatory risks, and enable timely execution.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
501-1,000 employees
