HIPAA FDA 21 CFR

Part 11 GMP GDPR compliance expertise Quality risk management Healthcare privacy protection Laboratory compliance Health information regulatory compliance CLIA regulations Regulatory submission editing and review Biomedical regulatory compliance Communication with regulatory authorities for clinical trials Clinical quality assurance standards Molecular biology Full Job Description 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 the bay area of 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 Associate Director, Global Regulatory Affairs supports the vision, and strategic direction for the company's global regulatory function. This role reports to the Vice President, Head of Regulatory and is accountable for driving regulatory strategy across all portfolios—with a focus on diagnostics and device commercialization—influencing external regulatory policy, and ensuring global compliance in alignment with corporate objectives. The Associate Director/Director partners closely with executive leadership to guide portfolio and business-critical decisions, supports the company by preparing materials and presentations required for high-level interactions with health authorities, and develops the next generation of regulatory leaders. This is a hybrid role based in Washington, D.C. Our current flexible work arrangement policy requires that a minimum of 40%, or 16 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with the team and business needs and could exceed the 40% requirement for the site.

Responsibilities:

Define and oversee global regulatory strategies for the company's full product portfolio, ensuring alignment with business priorities and global requirements. Drive diagnostics and/or medical device commercialization across key international markets, specifically the EU, Asia/Pacific, the Middle East (including Israel and Saudi Arabia), and the UK. Working closely with Senior executives, provide strategy and oversight for all regulatory submissions, product approvals, and lifecycle management activities across geographies. Partner with cross-functional teams, and executive leadership (R D, Quality, Clinical, Commercial, Manufacturing) to integrate regulatory considerations into enterprise strategy and portfolio governance. Anticipate global regulatory and policy shifts, assess impact, and shape proactive company responses. Ensure organizational readiness for regulatory inspections, audits, and authority interactions at the highest level. Influence international regulatory policy through participation in industry forums, standards bodies, and regulatory working groups. Champion innovation and transformation initiatives within the regulatory function, including digital enablement, automation, and process modernization.

Required Qualifications:

Advanced degree in molecular biology, genomics, or diagnostics; PhD preferred. 15+ years of relevant regulatory affairs or related industry experience; Master's degree with 12+ years, or PhD with 10+ years Proven record of success leading enterprise-level regulatory strategies and high-impact submissions, particularly with experience in international diagnostics/device commercialization. Extensive experience interacting at senior levels with global regulatory agencies and influencing international policy Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity, including Regulatory submission of medical devices (e.g., IVDD, IVDR, FDA 21 CFR, UK

MDR 2002

) GMP quality management systems (e.g., ISO 13485) and Risk assessment frameworks (e.g., ISO 14971) Clinical laboratory regulations (e.g., CAP, CLIA, NYSDOH, ISO 15189) Protected health information (e.g., HIPAA, GDPR) Development and Operations within a regulated clinical study environment (e.g., ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54, Part 56)

Preferred Qualifications:

Global regulatory expert with mastery of U.S., EU, and international frameworks, submission pathways, and compliance requirements Exceptional communication and influencing skills, with credibility at the executive and global health authority levels. Strong portfolio and enterprise decision-making capability, balancing regulatory risk, innovation, and business priorities. Advanced proficiency in enterprise regulatory systems, global submission platforms, and compliance tools.

Physical Demands and Work Environment:

Leadership role with broad, global scope and strategic impact and opportunity to grow. Requires flexibility to operate across multiple time zones and respond to urgent global regulatory needs. Extensive domestic and international travel required for regulatory negotiations, industry representation, and leadership responsibilities. As the organization evolves, the employee must be adaptable to taking on additional responsibilities, new technologies, or cross-functional projects to meet changing business needs The expected, full-time, annual base pay scale for this position is $146K - $194K. Actual base pay will consider skills, experience, and location. This role may be eligible for other forms of compensation, including an annual bonus and/or incentives, subject to the terms of the applicable plans and Company discretion. This range reflects a good-faith estimate of the range that the Company reasonably expects to pay for the position upon hire; the actual compensation offered may vary depending on factors such as the candidate's qualifications. Employees in this role are also eligible for GRAIL's comprehensive and competitive benefits package, offered in accordance with our applicable plans and policies. This package currently includes flexible time-off or vacation; a 401(k) retirement plan with employer match; medical, dental, and vision coverage; and carefully selected mindfulness programs. GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, disability, status as a protected veteran, , or any other class or characteristic protected by applicable federal, state, and local laws. Additionally, GRAIL will consider for employment qualified applicants with arrest and conviction records in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities. Please contact us at [email protected] if you require an accommodation to apply for an open position. GRAIL maintains a drug-free workplace. 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Associate Director, Global Regulatory Affairs # 4809