Director, International Regulatory Affairs (Diagnostics)

Location: Remote in the USA, or hybrid in London, UK with at least 40% (16 hours per week) onsite. Domestic and international travel is required, with flexibility across multiple time zones.

Company

hirify.global develops diagnostic products and is advancing the commercialization of Galleri across international markets.

What you will do

• Define and oversee global regulatory strategies for the product portfolio.
• Lead international regulatory submissions, product approvals, registrations, and lifecycle management.
• Drive Galleri commercialization across the EU, Asia/Pacific, the Middle East, including Israel and Saudi Arabia, and the UK.
• Partner with executive leadership and R&D, Quality, Clinical, Commercial, and Manufacturing teams on portfolio and business decisions.
• Prepare for regulatory inspections, audits, and senior-level health-authority interactions.
• Influence international regulatory policy and modernize the function through digital enablement and automation.

Requirements

• Advanced degree in molecular biology, genomics, or diagnostics required; PhD preferred.
• At least 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 experience leading enterprise-level regulatory strategies and high-impact international diagnostics or medical-device submissions.
• Senior-level experience engaging global regulatory agencies and influencing international policy.
• Knowledge of medical-device regulations and standards, including IVDD, IVDR, FDA 21 CFR, UK MDR 2002, ISO 13485, and ISO 14971.
• Knowledge of clinical laboratory, privacy, and regulated clinical-study requirements, including CAP, CLIA, NYSDOH, ISO 15189, HIPAA, GDPR, ICH E6, ISO 20916, and FDA 21 CFR Parts 11, 50, 54, and 56.

Nice to have

• Mastery of US, EU, and international regulatory frameworks, submission pathways, and compliance requirements.
• Advanced proficiency with enterprise regulatory systems, global submission platforms, and compliance tools.
• Exceptional communication, influencing, portfolio, and enterprise decision-making skills.

Culture & Benefits

• Strategic leadership role with global scope and significant organizational impact.
• Flexible time off or vacation.
• 401(k) retirement plan with employer match.
• Medical, dental, and vision coverage.
• Mindfulness programs and potential annual bonus or incentive compensation.