Head of Regulatory Strategy & Clinical Development

Eyebot • Boston, MA

3d • $160,000 - $195,000 • Hybrid

About The Position

Eyebot is looking for a Head of Regulatory Strategy & Clinical Development to own our path to market. You'll define and execute FDA regulatory strategy for our AI-enabled ophthalmic diagnostic platform, including 510(k) submissions, Pre-Subs, and CE marking under EU MDR while leading the clinical evidence strategy that supports it. This is a hands-on leadership role with direct executive visibility and a direct line to product impact.
This is a hybrid role based out of our North End or Charlestown offices in Boston . We work together in person 4–5 days per week - we find the energy and collaboration of being together in person makes a real difference, especially at this stage of the company.

Requirements

• 6–12 years of medical device regulatory experience
• Proven, hands-on ownership of successful 510(k) submissions - you wrote them, you led them
• 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)

Nice To Haves

• Ophthalmic device experience strongly preferred

Responsibilities

• Define and execute overall FDA regulatory strategy, including predicate selection, intended use framing, and risk positioning
• Author and lead Pre-Submission and 510(k) filings from first draft through clearance
• Serve as Eyebot's primary point of contact for FDA meetings, Q-Subs, and official correspondence
• Align risk management, labeling, and software documentation with FDA expectations under applicable device software guidance
• Lead EU MDR regulatory strategy and own the CE marking pathway end-to-end
• Develop and maintain the Technical File; manage Notified Body interactions and audits
• Oversee post-market surveillance and vigilance strategy; ensure alignment between U.S. and EU regulatory positions
• Determine when clinical evidence is required and define scope of evidence needed
• Design clinical study protocols and statistical analysis plans
• Oversee IRB submissions, site coordination, study execution, data quality, and final study reports
• Own regulatory program timelines across hardware, software, clinical, and labeling workstreams
• Provide regulatory guidance to engineering and product teams throughout development
• Present regulatory strategy, risk assessments, and timelines to executive leadership
• Ensure alignment with ISO 14971 risk management and applicable device standards

Benefits

• Meaningful equity - you're building this with us and should share in what we create
• Flexible work schedule with unlimited PTO - we care about the work you do, not the hours you log
• Health, dental, and vision insurance
• Employer-sponsored 401(k)
• Commuter support and wellness benefits - including tools like Calm and Cariloop to help you perform at your best
• A culture where all ideas are welcome, no matter how out there — that's how Eyebot started, and it's how we keep moving forward
• A collaborative office in Boston's North End, with regular team lunches and a waterfront view
• The opportunity to build products that improve lives and reshape how vision care is delivered.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: No Education Listed