Director, Medical Affairs And Policy (AI)

TL;DR

Director, Medical Affairs and Policy (AI): Leading the integrated strategy for post-market clinical evidence, medical affairs, and government relations for AI-enabled medical imaging products with an accent on regulatory compliance, reimbursement advocacy, and KOL engagement. Focus on building robust clinical evidence frameworks, navigating global health policy landscapes, and ensuring the long-term commercial success of SaMD solutions.

Location: Must be based in the United Kingdom

Company

hirify.global is a healthcare technology company developing diagnostic AI solutions to support clinicians and improve patient outcomes globally.

What you will do

• Lead the global post-market clinical evidence roadmap for the SaMD portfolio.
• Oversee the design and reporting of real-world evidence studies and clinical performance evaluations.
• Manage KOL and site engagement strategies to support product adoption and research.
• Direct the medical review of product claims and promotional materials for regulatory compliance.
• Develop and implement government relations strategies to support market access and reimbursement.
• Represent the company in policy forums, industry associations, and international health technology assessments.

Requirements

• Advanced degree in Medicine, life sciences, or medical science.
• Experience in clinical program management and study design within the medical device or pharmaceutical industry.
• Proven experience in research involving AI, SaMD, or medical imaging.
• Deep understanding of regulatory requirements for clinical studies (FDA, TGA, EU).
• Knowledge of Good Machine Learning Practice, ICH GCP, and ISO 14155 standards.

Nice to have

• PhD or post-graduate qualification in a relevant medical science field.
• 10+ years of experience in the medical device or pharmaceutical industry.
• 3+ years of experience in the validation of AI-based SaMD products.
• Ability to interpret complex diagnostic accuracy metrics and clinical data.

Culture & Benefits

• Flexible work environment with WFH options and autonomy.
• Yearly learning and development budgets with mentoring opportunities.
• Inclusive family support policies covering all stages of parenthood.
• Collaboration with a global, well-funded team backed by world-class investors.