🛠 Tech Stack

💼 About This Role

You'll define and operationalize the long-term regulatory vision for an AI-driven medical technology company during a pivotal growth phase. You'll architect global regulatory infrastructure and position Regulatory Affairs as a strategic enabler of innovation and competitive differentiation. This role reports to the Chief Regulatory Officer and directly impacts enterprise risk posture and market strategy.

🎯 What You'll Do

• Define and execute the long-term regulatory strategy aligned with corporate growth objectives.
• Architect regulatory strategies for modular AI systems and independent algorithm iteration.
• Lead regulatory assessments for expansion into new clinical workflows and treatment planning.
• Operationalize global market access under an 'assess once, submit many' framework.

📋 Requirements

• 15+ years of regulatory affairs experience in medical devices or diagnostics.
• 5+ years of leadership experience in a strategic regulatory role.
• Deep experience with AI/ML-enabled software and SaMD global regulations.
• Proven track record of FDA submissions and international registrations.

✨ Nice to Have

• Experience in cardiology or imaging diagnostics.
• Familiarity with RIM systems and digital regulatory infrastructure.
• Advanced degree (MS, PhD) in a relevant scientific field.

🎁 Benefits & Perks

• 🏖️ Flexible remote work with access to offices in Denver, NYC, Dallas, Lisbon.
• 💰 Competitive equity in a well-funded Series C company.
• 🏥 Comprehensive health insurance (medical, dental, vision).
• 📚 Professional development budget and RAPS certification support.
• ✈️ Travel for team meetings once per month/quarter.

📨 Hiring Process

Estimated timeline: 3-5 weeks · AI estimate

1. 1Recruiter Phone Screen· 30 min
2. 2Hiring Manager Interview· 60 min
3. 3Executive Interview· 60 min

🚩 Heads Up

• Travel requirement up to 50-90% for this role may conflict with remote descriptor.