Clinical and Regulatory Lead
Position Overview
Neuraworx Medical Technologies is a seed-stage medical device startup developing a wearable neurostimulation platform aimed at traumatic brain injury (TBI) and other CNS disorders—conditions where patients urgently need better options.
Our feasibility studies 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 at Neuraworx. You 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.
Experience with neuromodulation, TBI, or CNS disorders.
Prior startup or early-stage company experience.
Experience with sleep studies.
Experience in clinical, regulatory, quality.
Familiarity with electronic data capture (EDC) systems and clinical data management best practices.
What We're Looking For
Beyond formal qualifications, we seek a person with these characteristics:
Operational depth with strategic breadth: You can design the high-level strategy but are also able/interested in hands-on site calls and document review.
Intellectual humility: Willingness to learn unfamiliar domains and seek expertise from others.
Bias toward action: Comfortable making decisions with imperfect information; avoids analysis paralysis.
Collaborative problem-solver: Enjoys working across disciplines (Engineering, Regulatory, Business) and bringing different perspectives together.
Translational thinker: Able to understand engineering constraints, translate them to clinical possibilities, and explain clinical realities to business stakeholders.
Hands-on leadership: Wants to stay engaged in the details of the trials, not just delegate.
What We Offer
Significant hands-on work: You’ll spend ~60% of your time actively managing clinical execution, ~40% on leadership, strategy, and cross-functional alignment.
Equity ownership: Meaningful equity stake reflecting your pivotal role in shaping the company’s clinical success.
Growth trajectory: Clear advancement path as the company scales.
Resources & autonomy: Freedom to help build the clinical function the right way from the ground up; budget and decision-making authority commensurate with the role.
Impactful mission: Develop technology that could meaningfully improve patients’ lives; avoid “me-too” products in favor of genuine innovation.
Collaborative culture: Work directly with CEO and co-founders who value clinical input in strategic decisions.
Learning environment: Access to leading neurotech experts, clinical sites, and clinical advisors; opportunity to deepen expertise across multiple domains.
How to Apply
Send resumes to chris@neuraworx.com
Tell us about your most significant clinical trial challenge and how you solved it.
Describe your experience managing clinical sites—what worked well, and what didn’t?
What aspects of TBI/CNS clinical studies or neurostimulation excite or intrigue you most?
About the Role's Evolution
This is a founding position, and its scope will evolve. Initially, you will be the primary clinical and regulatory resource, reporting directly to the CEO/Cofounder. As we grow and initiate larger studies, you may help build a team of specialized clinical and regulatory staff (CRAs, Clinical Project Managers, and Regulatory Specialists). Success in this role is defined by the quality of clinical evidence delivered and regulatory milestones achieved, not by headcount managed.