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
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. We welcome job-seekers from all backgrounds to join us!
Skills Required
- Advanced degree in molecular biology, genomics, or diagnostics
- PhD (preferred)
- 15+ years of relevant regulatory affairs or related industry experience (Master's with 12+ years or PhD with 10+ years acceptable)
- Proven record leading enterprise-level regulatory strategies and high-impact submissions
- Experience in international diagnostics and/or medical device commercialization
- Extensive experience interacting at senior levels with global regulatory agencies and influencing international policy
- Regulatory submission knowledge for medical devices (e.g., IVDD, IVDR, FDA 21 CFR, UK MDR 2002)
- GMP quality management systems knowledge (e.g., ISO 13485) and risk assessment frameworks (e.g., ISO 14971)
- Clinical laboratory regulations knowledge (e.g., CAP, CLIA, NYSDOH, ISO 15189)
- Protected health information regulatory knowledge (e.g., HIPAA, GDPR)
- Development and operations knowledge within regulated clinical study environments (e.g., ICH E6 GCP, ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54, Part 56)
- Mastery of U.S., EU, and international regulatory frameworks and submission pathways
- Exceptional communication and influencing skills with credibility at executive and health authority levels
- Strong portfolio and enterprise decision-making capability balancing regulatory risk and business priorities
- Advanced proficiency in enterprise regulatory systems, global submission platforms, and compliance tools
What the Team is Saying
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GRAIL Compensation & Benefits Highlights
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Healthcare Strength — Multiple medical plan options, comprehensive medical/dental/vision coverage, and strong mental health programs are described, with employer HSA contributions up to $3,000 for the HDHP. These elements indicate a well‑rounded health offering.
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Leave & Time Off Breadth — Flexible time off is highlighted, with examples of unlimited/FTO policies working well in practice. Paid holidays and company winter breaks further support time away from work.
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Equity Value & Accessibility — New‑hire equity grants that vest over four years and a discounted Employee Stock Purchase Plan are positioned as meaningful parts of total compensation. Ongoing eligibility for additional equity is also noted.
GRAIL Insights
What We Do
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is using the power of high-intensity sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop and commercialize pioneering products.
Why Work With Us
Everything we do is guided by our mission to detect cancer early, when it can be cured. It’s the reason we’re here, and it’s no small task. The right people make all the difference. That’s why we’re looking for those who strive to share their knowledge, contribute their skills, inspire each other and commit to something bigger than themselves.
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GRAIL Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
GRAIL has a variety of work types depending on the roles. Some roles are onsite like a lab role, some are fully remote like our Galleri Sales Consultant roles. Others are hybrid with 2-3 days onsite. Typically Tuesday and Thursday.
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