FDA Regulatory Consultant Needed for Digital Therapeutic (SaMD) – Anxiety Reduction App

Project Overview: The Tapping Solution is exploring FDA 510(k) clearance for a software-based behavioral intervention focused on acute anxiety reduction. We have unusually strong real-world evidence (RWE) from over 1.4 million paired pre/post anxiety sessions, and we are beginning the process of defining our regulatory pathway, evidence plan, and Q-Submission strategy. We are seeking a highly experienced FDA regulatory consultant with a background in digital therapeutics (DTx) and Software as a Medical Device (SaMD) to guide us through the correct pathway (Class II 510(k)), ensure our evidence package meets FDA expectations, and participate in a pre-submission meeting with the agency. ⸻ ⭐ Responsibilities Regulatory Strategy • Evaluate whether our product fits a Class II 510(k) / OTC behavioral health indication. • Identify appropriate predicate devices and advise on substantial equivalence. • Help define FDA-appropriate indication for use language and claims limitations. Evidence & Clinical Plan • Assess our existing RWE dataset and determine what additional evidence (if any) is needed. • Help design a small pragmatic study (100–200 participants) if FDA requests prospective data. • Prepare an integrated RWE + clinical evidence strategy that minimizes time and cost. Q-Submission Preparation • Draft the Pre-Submission briefing package (device description, indications, risk analysis, evidence summary, questions for FDA). • Prepare the CEO and team for the meeting (talking points, risk areas, data presentation). • Attend the FDA Pre-Sub meeting with us. SaMD & QMS Guidance • Outline what is required to bring a single module of our app under a quality management system (QMS). • Help us understand change control, software documentation requirements, and risk categorization. ⸻ ⭐ Required Experience Please apply ONLY if you have: • 5+ years of FDA regulatory experience with SaMD or digital therapeutics • Direct experience with Class II medical device 510(k) submissions • Experience preparing or leading FDA Q-Sub / Pre-Submission meetings • Strong familiarity with behavioral health, relaxation, or neuromodulation devices • Understanding of how FDA evaluates real-world evidence in SaMD submissions Preferred but not required: • Former FDA reviewer (Digital Health Center of Excellence or CDRH) • Experience with companies like Pear Therapeutics, Big Health, Freespira, NightWare, Woebot, Happify, etc. ⸻ ⭐ Deliverables • Written regulatory pathway assessment • Draft indication for use and risk analysis • Predicate comparison analysis • Draft of the Q-Sub briefing document • Participation in the FDA pre-submission meeting • Written recommendations post-meeting ⸻ ⭐ What We Bring to the Table • Over 32M completed sessions in our app • A unique RWE dataset with 1.4M paired anxiety measurements • Active research collaboration with a major academic institution • A clean, standardized, low-risk behavioral intervention • A fully developed consumer app requiring only a “walled-off” medical module ⸻ ⭐ To Apply Please include: 1. A brief summary of your FDA / SaMD regulatory experience 2. Examples of relevant 510(k) submissions or Q-Subs you’ve supported 3. Your hourly rate or project estimate 4. Whether you have behavioral health or neuromodulation-specific experience Apply tot his job Apply To this Job