Clinical and Regulatory Lead

s are underway. Our product is progressing rapidly. Now we’re looking for a Clinical and Regulatory Lead who wants to do more than “oversee trials”—someone who wants to build the clinical engine from the ground up and help carry a novel technology from concept into first-in-human impact.

This is a hands-on, high-ownership role for a clinical leader who thrives in early-stage environments and is energized by turning scientific potential into credible clinical evidence.

As Clinical and Regulatory Lead, you are the architect, operator, and steward of all clinical activities will design and execute our early human studies, establish our clinical roadmap, and serve as the connective tissue between engineering, regulatory, advisors, investigators, and leadership. You also will architect our strategy for the FDA from our Quality Management System to FDA clearance of our product.

You will spend meaningful time in the details—protocols, sites, data, and documentation—while also shaping strategy, milestones, and long-term clinical direction.

If you enjoy rolling up your sleeves and building something that matters, this role was designed for you.
Key Responsibilities Strategic Leadership & Study Design
• Design, author, and execute clinical studies from protocol through closeout, including IRB support documentation and case report forms.
• Define the clinical roadmap and critical path milestones that support regulatory and commercialization goals.
• Serve as primary liaison to the Scientific Advisory Board: coordinate meetings, prepare materials, and translate insights into action.
• Communicate clinical progress and risks clearly to executive leadership and investors.
• Define the clinical roadmap and critical path milestones to support the company’s broader commercialization strategy.
Clinical Operations & Execution
• Lead day-to-day clinical operations: site onboarding, recruitment support, scheduling, sample logistics, monitoring, and data collection.
• Manage relationships with clinical sites, reference labs, and fractional clinical/regulatory partners.
• Ensure clinical data are accurate, traceable, and inspection-ready.
• Deliver studies on time and on budget without compromising scientific rigor or patient safety.
Regulatory & Quality Compliance
• Lead regulatory strategy for the company including clinical strategy, FDA clearance strategy, and the company’s QMS.
• Own regulatory submissions (IRB, FDA) and ensure ongoing compliance.
• Support and operate within the company’s QMS in alignment with ISO 13485, GCP, and 21 CFR Part 820.
• Oversee adverse event reporting, risk management activities, and CAPAs as applicable.
Team Building & Culture
• Build and lead a high-performance clinical team as the company grows.
• Set the tone for compliance, transparency, and patient-centered decision-making.
• Translate complex clinical realities into clear, actionable insights for engineers, business leaders, and board members.
Required Qualifications
• BS or MS in a life science, biomedical engineering, nursing, or regulatory/quality discipline.
• 7+ years’ progressive clinical research experience, preferably including hands-on trial management for medical devices in the US.
• Track record of developing protocols, authoring IRB and FDA submissions, and operating in lean, cross-functional environments.
• Broad knowledge of medical device GCP, ISO 13485, 21 CFR Part 820, and QMS operations.
• Demonstrated leadership, communication, and problem-solving skills in a fast-moving, multidisciplinary setting.
• Entrepreneurial mindset: comfort with ambiguity, ability to prioritize effectively with limited resources, and enthusiasm for building something from the ground up.
Preferred Qualifications
• Experience with Scientific Advisory Boards or KOL engagement.
• Wearable medical device experience or network.
• Exp…