Head of Regulatory Strategy & Clinical Development

Eyebot is an outcome-focused technology company seeking a Head of Regulatory Strategy & Clinical Development to define and execute FDA regulatory strategy and lead clinical evidence strategy for its AI-enabled ophthalmic diagnostic platform.

Requirements

• 6-12 years of medical device regulatory experience
• Proven ownership of successful 510(k) submissions
• Direct experience with EU MDR and the CE marking process
• Experience leading or preparing FDA Q-Sub or Pre-Sub meetings
• Background with Class II diagnostic or electromechanical devices
• Strong regulatory writing and documentation skills
• Familiarity with device software and current FDA guidance in this area (SaMD, AI/ML)
• Ophthalmic device experience strongly preferred

Benefits

• Flexible work schedule
• Unlimited PTO
• Health, dental, and vision insurance
• Employer-sponsored 401(k)
• Commuter support and wellness benefits