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.⭐ ResponsibilitiesRegulatory 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 ExperiencePlease 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 submissionsPreferred 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 ApplyPlease include:1.A brief summary of your FDA / SaMD regulatory experience2. Examples of relevant 510(k) submissions or Q-Subs you’ve supported3. Your hourly rate or project estimate4. Whether you have behavioral health or neuromodulation-specific experience Apply tot his job