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Director, International Regulatory Affairs #4809

1 month, 2 weeks ago
United States, United Kingdom
Full-time
Executive
Compliance Manager
Operations
HIPAA
Apply Now
GRAIL

GRAIL

GRAIL is a healthcare company pioneering early cancer detection with the Galleri™ blood test, using advanced technology to save lives and improve health.

Health Care Providers & Services
1K-5K
Founded 2015
$1700M raised
View All Jobs 5

Description

  • Define and oversee global regulatory strategies for the product portfolio in alignment with business priorities.
  • Drive Galleri commercialization across the EU, Asia-Pacific, Middle East, Israel, Saudi Arabia, and the UK.
  • Oversee regulatory submissions, product approvals, and lifecycle management across geographies.
  • Partner with executive leadership and R&D, Quality, Clinical, Commercial, and Manufacturing teams on portfolio governance.
  • Anticipate regulatory and policy changes and develop proactive company responses.
  • Prepare the organization for regulatory inspections, audits, and high-level health authority interactions.
  • Influence international regulatory policy through industry forums, standards bodies, and working groups.
  • Lead international submissions, product registrations, filing strategies, timelines, and governance.
  • Maintain regional registrations, regulatory records, commitments, databases, and post-approval activities.
  • Advance regulatory innovation through digital enablement, automation, and process modernization.

Requirements

  • Advanced degree in molecular biology, genomics, diagnostics, or a related field; PhD preferred.
  • 15+ years of relevant regulatory affairs or industry experience, or 12+ years with a master’s degree or 10+ years with a PhD.
  • Proven success leading enterprise-level regulatory strategies and high-impact international diagnostics or device submissions.
  • Extensive experience engaging senior global regulatory agencies and influencing international policy.
  • Knowledge of medical device regulations, including IVDD, IVDR, FDA 21 CFR, and UK MDR 2002.
  • Knowledge of GMP quality systems and risk frameworks, including ISO 13485 and ISO 14971.
  • Knowledge of clinical laboratory regulations, including CAP, CLIA, NYSDOH, and ISO 15189.
  • Knowledge of privacy and protected health information requirements, including HIPAA and GDPR.
  • Knowledge of regulated clinical study standards, including ICH E6, ISO 20916, and applicable FDA 21 CFR requirements.
  • Experience with US, EU, and international submission pathways, regulatory systems, EUDAMED, Saudi GHAD, and UAE MOHAP; ability to work across time zones and travel internationally.

Benefits

  • US base salary of $169,000–$242,000 annually.
  • Potential annual bonus and/or incentive compensation.
  • Flexible time off or vacation.
  • 401(k) retirement plan with employer match.
  • Medical, dental, and vision coverage.
  • Mindfulness and wellness programs.
  • US-remote or London hybrid work arrangement; UK hybrid employees work on-site at least 40% of the week.

Interested in this position?

Apply directly on the company website

Apply Now

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