Regulatory and Clinical Lead

 

Open Position – Regulatory and Clinical Lead

Horizon Surgical Systems Inc.

 

Horizon Surgical Systems Inc. is revolutionizing the world of surgical ophthalmology by developing a novel, AI driven, and imaging-guided surgical robotic system. Horizon Surgical Systems Inc. aims to expand access to care, provide superior capabilities to the human surgeon, and enhance patient outcomes. Microsurgery in general and Ophthalmology are subfields of surgery for which the surgical outcomes can be significantly improved by robotic systems to allow superior dexterity, precision, accuracy, and visualization beyond the human surgeon’s own capabilities.

We are seeking highly motivated, and intellectually inquisitive individuals looking to make a positive impact on healthcare via the development of robotic technology. The core values of Horizon Surgical Systems Inc. are:

• Commitment to Excellence: We aim to deliver superior patient outcomes and surgeon experiences
• Passion for Creativity and Innovation: We are driven by new ideas and aim to push the boundaries of what's possible
• Teamwork and Camaraderie: We achieve our best when we collaborate and work together
• Welcoming of Critical Opinion: We are enriched by constructive criticism and support the best ideas
• Personal Accountability: We honor our commitments and take responsibility for our actions

 

Horizon Surgical Systems Inc. offers:

• An opportunity to build autonomous surgical robotic systems driven by image guidance and AI technology for the future of affordable, high-quality healthcare.
• The opportunity to work alongside clinicians, engineers, and global leaders in cutting-edge AI, imaging, and robotics technology.
• Competitive compensation and an excellent company-paid benefits package.

Role Description: 

As the Regulatory and Clinical Lead, you will leverage your experience in regulatory strategy and clinical study oversight to drive the development of FDA-regulated medical products. In this role, you will coordinate regulatory submissions, design and manage clinical trials, and ensure alignment with business and compliance milestones—ultimately delivering safe, effective, and commercially viable solutions that improve patient outcomes and support the broader healthcare ecosystem.

Required Qualifications & Abilities:

Focus: Regulatory and Clinical activities (Note: QA is handled by our existing QA lead)

• Regulatory
  - Coordinate interactions with consultants to define and execute the regulatory strategy (including FDA information meetings, Q-Subs, IDE submissions, etc.)
  - Submission requirements and deliverables checklist
  - Maintenance of submission timelines, documentation, and regulatory compliance
  - Align regulatory strategy with business milestones and timelines
  
  
• Clinical
  - Design and oversee clinical studies to support regulatory approvals, including defining endpoints, sample sizes, and protocols
  - Prepare Clinical Evaluation Reports and related documentation
  - Oversight of clinical site selection, onboarding, and trial execution
  - Select independent IRB and coordinate submission by each clinical site
  - Define clinical evidence needed to support regulatory submissions and commercial use
  - Ensure GCP compliance throughout all study activities
  - Determine biostatistics plan and ensure data management requirements
  
  
• Operational responsibilities-
  - Manage day-to-day clinical and regulatory operations, including:
  - Coordination with external consultants, CROs, and regulatory bodies 
  - Provide regulatory input and support to cross-functional teams during development
  - Collaborate with R&D, Quality, and Product teams to align regulatory and clinical activities with product development timelines

 

This is an exciting opportunity to join a high-tech startup that is poised to revolutionize surgical robotics in ophthalmology.