Vice President, Regulatory Strategy and Innovation (AI)

TL;DR

Vice President, Regulatory Strategy and Innovation (AI/MedTech): Defining and operationalizing the long-term regulatory vision for an AI-driven heart disease diagnostic platform with an accent on global expansion, modular software architecture, and AI-enabled regulatory intelligence. Focus on architecting global regulatory infrastructure, navigating novel AI pathways, and influencing global health authority frameworks.

Location: Virtual US

Base Salary: $280,000 - $300,000; Total Target Compensation: $336,000 - $360,000

Company

hirify.global is a healthcare company revolutionizing the diagnosis and treatment of heart disease through AI-driven precision diagnostic solutions.

What you will do

• Define and execute the long-term global regulatory strategy aligned with corporate growth and portfolio expansion.
• Architect regulatory strategies for modular AI systems and independent iteration of AI algorithms.
• Operationalize market access in EMEA and GCC regions using a harmonized technical documentation framework.
• Lead the implementation of Regulatory Information Management (RIM) systems and AI-enabled regulatory intelligence.
• Serve as the primary executive representative before global regulatory authorities and influence AI/ML medical device frameworks.
• Build and mentor a high-performing leadership team of Directors and Senior Managers.

Requirements

• Must be based in the US.
• 15+ years of Regulatory Affairs experience, specifically with SaMD and AI/ML-enabled medical technologies.
• 7–10 years of leadership experience managing multi-level teams.
• Proven expertise in EU MDR and international frameworks, including GCC markets.
• Deep knowledge of SDLC, agile, IEC 62304, and ISO 14971.
• Ability to travel up to 40% of the time.
• B.S. in Life Science or Engineering; JD and RAC certification are highly preferred.

Culture & Benefits

• Remote-first culture with access to physical offices in several US cities and Lisbon.
• Performance-based 20% target annual bonus.
• Comprehensive total rewards including stock options and paid benefits.
• Core values centered on Humility, Excellence, Accountability, Remarkable impact, and Teamwork.