Regulatory and Clinical Lead

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
• 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

Benefits

• Competitive compensation and an excellent company-paid benefits package
• Base Salary Range: $180k - $250k, dependent on experience
• Total compensation includes stock options and end of year bonus