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 bolthires. 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 tot his job Apply tot his job

Apply tot his job Apply To this Job