Regulatory Affairs Associate Director, IVD # 4432
Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com. The role assists with regulatory strategy and the development of submissions in partnership with key internal and external stakeholders for GRAIL projects, including Multi-Cancer Early Detection (MCED). The position supports the U.S. Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements, pre-submissions, Premarket Approvals (PMAs), annual reports, and other relevant documentation. The role collaborates cross-functionally with Quality, Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material review, on-market product support, and change control processes. This individual monitors and communicates changes in regulatory policies and In Vitro Diagnostic (IVD) requirements to project teams and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior management meetings as a delegate. The role fosters a work culture aligned with GRAIL’s values Expected full time annual base pay scale for this position is $164K-$205K. Actual base pay will consider skills, experience and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings. GRAIL is an Equal Employment Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us at [email protected] to request accommodation. GRAIL maintains a drug-free workplace. Apply tot his job Apply To this Job Apply tot his job Apply To this Job