Director/Associate Director, International Regulatory Affairs (Diagnostics)

Location: Sunnyvale, Washington, DC, or RTP, United States. The role requires flexibility across multiple time zones and domestic and international travel. The UK flexible-work policy requires at least 40% or 16 hours per week onsite.

Expected annual base pay: $169,000–$242,000, plus potential annual bonus or incentives.

Company

hirify.global is a healthcare and biotechnology company developing a multi-cancer early-detection blood test using next-generation sequencing, clinical studies, computer science, and data science.

What you will do

• Define and oversee global regulatory strategies for the product portfolio.
• Lead international submissions, product approvals, registrations, and lifecycle management activities.
• Drive Galleri commercialization across the EU, Asia/Pacific, the Middle East, including Israel and Saudi Arabia, and the UK.
• Establish filing strategies, submission plans, timelines, dependencies, and governance for international commercialization.
• Maintain regional registrations and regulatory records, including EU EUDAMED, UDI, Saudi Arabian GHAD, and UAE MOHAP systems.
• Partner with executive leadership and R&D, Quality, Clinical, Commercial, and Manufacturing functions on portfolio and enterprise decisions.

Requirements

• Advanced degree in molecular biology, genomics, or diagnostics; a PhD is preferred.
• 15+ years of relevant regulatory affairs or related 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 with global regulatory agencies, international policy, and senior-level health-authority interactions.
• Knowledge of IVDD, IVDR, FDA 21 CFR, UK MDR 2002, ISO 13485, ISO 14971, CAP, CLIA, NYSDOH, ISO 15189, HIPAA, GDPR, and regulated clinical-study standards.
• Ability to work from Sunnyvale, Washington, DC, or RTP, with flexibility across time zones and willingness to travel domestically and internationally.

Nice to have

• PhD in molecular biology, genomics, or diagnostics.
• Experience with digital enablement, automation, process modernization, and enterprise regulatory systems.

Culture & Benefits

• Strategic leadership role with global scope and broad organizational impact.
• Flexible time off or vacation.
• 401(k) retirement plan with employer match.
• Medical, dental, and vision coverage.
• Mindfulness programs and opportunities to work on new technologies and cross-functional initiatives.