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 SaMD and AI-enabled medical imaging products with an accent on evidence generation and reimbursement advocacy. Focus on designing real-world evidence studies, managing KOL relationships, and shaping health policy for global market adoption.

Location: Remote (Sydney, Australia)

Company

hirify.global is a healthcare AI company building diagnostic tools to scale global healthcare capacity and improve patient outcomes worldwide.

What you will do

• Develop and execute a global post-market clinical evidence roadmap for the SaMD portfolio.
• Oversee the design, reporting, and risk management of real-world evidence studies and performance evaluation summaries.
• Lead engagement and relationship management with Key Opinion Leaders (KOLs) and clinical partners globally.
• Conduct medical review and approval of product claims and promotional materials to ensure clinical accuracy and compliance.
• Implement government relations strategies to support regulatory clearance and public reimbursement in priority markets.
• Represent the company in policy forums and advocate for AI safety, transparency, and clinical value.

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.
• Background in research involving artificial intelligence, SaMD, and/or medical imaging.
• Proven experience working with regulatory bodies, including the FDA, TGA, and EU.
• Detailed knowledge of GMLP, ICH GCP, ISO 14155, and Data Privacy Laws.

Nice to have

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

Culture & Benefits

• Flexible work arrangement with WFH options and flexible hours.
• Annual L&D budgets, mentoring, hackathons, and a transparent growth framework.
• Inclusive family support policies covering fertility, parenthood, and loss.
• Collaborative, trust-based culture in a well-funded global environment.