💼 About This Role

You'll define and lead the enterprise regulatory strategy for a fast-scaling AI-driven medtech organization. You'll build scalable frameworks for AI/ML-enabled medical software and drive global market access in US, EU, and EMEA. This executive role positions regulatory affairs as a strategic enabler of innovation. No marketing fluff.

🎯 What You'll Do

• Define enterprise regulatory strategy aligning with product innovation and global expansion.
• Architect scalable regulatory frameworks for AI/ML-enabled software and modular architectures.
• Drive global market access strategy across US, EU, EMEA, and GCC.
• Establish governance models and policies for consistent compliant execution.
• Lead cross-functional alignment with Product, Engineering, Clinical, Legal, and Commercial teams.

📋 Requirements

• 15+ years of progressive regulatory affairs experience in SaMD and AI/ML-enabled medical technologies.
• Background in Class II/III medical devices, ideally cardiovascular or diagnostic imaging.
• Experience defining global regulatory strategy under EU MDR and other frameworks.
• Executive-level engagement with global regulatory authorities.
• Understanding of software development lifecycle and standards such as IEC 62304 and ISO 14971.

✨ Nice to Have

• Advanced degree or JD preferred.
• RAC certification strongly preferred.
• Experience implementing or modernizing RIM and eQMS platforms.

🎁 Benefits & Perks

• 💰 Competitive base salary of $280,000–$300,000.
• 🎯 Target annual bonus of 20% (total compensation $336k–$360k).
• 🏥 Comprehensive medical, dental, vision insurance.
• 🏖️ 401(k) retirement savings plan.
• 🏡 Fully remote-first work model with flexibility across the US.

🚩 Heads Up

• Approximately 40% travel required for a remote position.
• Role combines regulatory strategy with hands-on operational tasks like RIM/eQMS modernization.
• Extensive experience requirements (15+ years) may be challenging for some candidates.