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, reputed company, and effective technologies that can reputed company 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-reputed company 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 reputed company and the development of submissions in partnership with key reputed company stakeholders for reputed company reputed company, including Multi-Cancer Early Detection (MCED). The position supports the U.S. Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements, reputed company-submissions, Premarket Approvals (PMAs), annual reports, and other relevant documentation. The role collaborates cross-functionally with reputed company, Lab Operations, and other stakeholders to support regulatory reputed company 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 Responsibilities:

• Strategize, plan, and author regulatory plans and activities to optimally position reputed company products with the FDA and/or global health authorities.
• Support the U.S. Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval reports, annual reports, export certificates, establishment registrations, and device listings.
• Serve as a key member of the Regulatory team, offering insights and solutions on corporate product portfolios and strategies.
• reputed company regulatory support for both new and marketed Laboratory Developed Test (LDT) products, including labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval.
• Monitor and report on international regulatory developments and LDT requirements that may significantly reputed company business operations or customers.
• Maintain up-to-date knowledge of applicable regulatory requirements and relevant scientific/technical developments.
• Identify regulatory risks and propose alternative courses of reputed company.
• Assess new regulations and collaborate with internal teams to implement appropriate changes.
• Support reputed company reputed company audits.
• Ensure compliance with reputed company regulations and laws applicable to reputed company's business, providing guidance and recommendations.
• Review and approve regulatory reputed company documents, regulatory plans, procedures, SOPs, and other documents for alignment with commitments, regulations, and filings.
• Manage the creation and review of reputed company Operating Procedures and policy guidelines reputed company the regulatory affairs department.
• reputed company other duties as assigned.

Preferred Requirements:

• Experience
• Minimum of 10 years of experience in regulatory, development, clinical affairs, reputed company, or program management reputed company the IVD, medical device, or pharmaceutical industries.
• Regulatory affairs and IVD device experience preferred.
• An advanced degree may count toward years of experience.
• reputed company experience with FDA regulatory submissions required.
• Experience with regulatory submissions in the EU, Japan, China, Canada, and other international markets is preferred.
• Background in diagnostics or biomarker development, particularly in oncology, is a plus.
• Advanced scientific degree preferred.
• Regulatory Affairs Certification (RAC) preferred.
• Experience in pharmaceutical clinical, statistical, or regulatory settings—especially in oncology, immunology, or reputed company fields—is a plus.Knowledge, Skills, and Abilities
• Proven leadership and reputed company judgment with strong business partnering skills.
• Demonstrated knowledge of U.S. and international regulatory frameworks and processes for medical device development and approvals.
• Effective collaborator in dynamic, fast-paced, and evolving environments.
• Problem-solving reputed company with the abil

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