Head Of International Regulatory Affairs (AI)

TL;DR

Head of International Regulatory Affairs (AI): Spearheading international regulatory posture across telehealth, pharmaceuticals, and AI-driven clinical tools with an accent on market entry and global compliance. Focus on designing regulatory roadmaps for UK, EU, and other major markets and overseeing SaMD and AI/ML product strategies.

Location: Hybrid in London, England. Must be UK-based

Salary: £140K – £155K + Equity

Company

hirify.global is a leading health and wellness platform redefining healthcare through personalized, affordable, and accessible care from diagnosis to delivery.

What you will do

• Design and execute regulatory roadmaps to enable market expansion and product launches across the UK, EU, Canada, Australia, and Japan.
• Author and defend end-to-end dossiers, including UKCA/CE under MDR/IVDR, Health Canada submissions, TGA ARTG entries, and PMDA applications.
• Act as a strategic regulatory partner to international product, commercial, clinical, legal, and supply chain leaders.
• Own the international regulatory strategy for SaMD and AI/ML products, ensuring compliance with the EU AI Act and MHRA AI guidance.
• Serve as the official liaison to global agencies including MHRA, EMA, Health Canada, TGA, and PMDA.
• Establish foundational processes, technical playbooks, and regulatory frameworks to scale the international business.

Requirements

• 12+ years in Regulatory Affairs with a proven track record of clearing products in UK/EU, Canada, Australia, or Japan.
• Broad experience across medical devices/IVDs, SaMD/AI, pharmaceuticals/compounding, and telehealth.
• Fluency in EU MDR/IVDR, UKCA, and at least one additional major international regulatory framework.
• Deep understanding of emerging AI and digital health frameworks (EU AI Act, IMDRF SaMD).
• BSc or MSc in life sciences, pharmacy, biomedical engineering, or a related field.
• Must be based in the UK

Culture & Benefits

• Competitive salary and equity compensation.
• Unlimited PTO, company holidays, and quarterly mental health days.
• Offsite team retreats.
• Talent-first flexible and remote-friendly work approach.