Regulatory Affairs Associate Director, IVD # 4432

Grail Regulatory Affairs Position

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.

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. This job requires that a minimum of 60% or 3 days of the total work week be onsite in Durham, NC.

Responsibilities

Strategize, plan, and author regulatory plans and activities to optimally position GRAIL 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.

Provide 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 impact 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 action.

Assess new regulations and collaborate with internal teams to implement appropriate changes.

Support internal and external quality audits.

Ensure compliance with all regulations and laws applicable to GRAIL's business, providing guidance and recommendations.

Review and approve regulatory strategy documents, regulatory plans, procedures, SOPs, and other documents for alignment with commitments, regulations, and filings.

Manage the creation and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department.

Perform other duties as assigned.

Preferred Requirements

Minimum of 10 years of experience in regulatory, development, clinical affairs, quality, or program management within the IVD, medical device, or pharmaceutical industries.

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.

Regulatory Affairs Certification (RAC) preferred.

Experience in pharmaceutical clinical, statistical, or regulatory settingsespecially in oncology, immunology, or related fieldsis a plus.

Knowledge, Skills, and Abilities

Proven leadership and sound 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 mindset with the ability to work well across diverse teams.

Strong written and verbal communication skills.

Excellent organizational skills and attention to detail.

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 competitive benefit package, including flexible time-off, a 401(k) with a company % match, medical, dental, and vision insurance plans, and carefully selected mindfulness offerings, in accordance with our applicable plans and policies.

GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. It is GRAIL policy to provide equal employment opportunities without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, marital status, protected veteran status, disability status, medical condition, or any other class or characteristic protected by applicable federal, state, and local laws. This policy applies to all phases of employment, including, but not limited to : recruiting, hiring, training, promotion, and termination at all levels of employment. GRAIL maintains a drug-free workplace. Additionally, GRAIL will consider all qualified job-seekers with criminal histories in a manner consistent with applicable law and provide reasonable accommodations to qualified 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 rc@grailbio.com if you require an accommodation to apply for an open position. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.