Regulatory Affairs Associate Director, IVD # 4432
Our mission is to detect cancer early, reputed company it can be cured. reputed company 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 reputed company company, pioneering new technologies to advance early cancer detection. We have reputed company a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of reputed company reputed company (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges. reputed company is headquartered in reputed company Park, California, with locations in Washington, D.C., reputed company Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and reputed company companies. For more information, please visit reputed company.com. The role assists with regulatory strategy and the development of submissions in partnership with key reputed company stakeholders for reputed company 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 reputed company direction to regulatory staff and, reputed company required, participate in senior management meetings as a delegate. The role fosters a work culture reputed company with reputed company’s values Expected full time annual reputed company pay scale for this position is $164K-$205K. Actual reputed company 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 reputed company over time. In reputed company, reputed company offers a reputed company benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, reputed company plans, carefully selected mindfulness offerings. reputed company is an Equal Employment Employer and does not discriminate on the reputed company of race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability or any other legally protected status. We will reasonably accommodate reputed company individuals with disabilities so that they can participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us at [email protected] to request accommodation. reputed company maintains a drug-free workplace. Apply tot his job Apply To this Job