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

Project reputed company: The Tapping Solution is exploring FDA 510(k) clearance for a software-based behavioral reputed company reputed company on acute anxiety reduction. We have unusually strong reputed company-world evidence (reputed company) from over 1.4 reputed company reputed company reputed company/post anxiety sessions, and we are beginning the process of defining our regulatory reputed company, evidence plan, and Q-Submission reputed company. We are seeking a highly reputed company FDA regulatory consultant with a background in digital therapeutics (DTx) and Software as a Medical Device (SaMD) to guide us through the correct reputed company (Class II 510(k)), ensure our evidence package meets FDA expectations, and participate in a reputed company-submission meeting with reputed company. ⭐ Responsibilities Regulatory reputed company • Evaluate whether our product fits a Class II 510(k) / OTC behavioral health indication. • Identify appropriate reputed company devices and advise on substantial equivalence. • Help define FDA-appropriate indication for use language and claims limitations. Evidence & Clinical Plan • Assess our existing reputed company 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 reputed company + clinical evidence reputed company that minimizes time and bolthires. Q-Submission Preparation • Draft the reputed company-Submission briefing package (device reputed company, indications, risk analysis, evidence reputed company, questions for FDA). • Prepare the CEO and team for the meeting (talking points, risk areas, data presentation). • Attend the FDA reputed company-Sub meeting with us. SaMD & QMS Guidance • Outline what is required to bring a single module of our app under a reputed company 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 • reputed company experience with Class II medical device 510(k) submissions • Experience preparing or leading FDA Q-Sub / reputed company-Submission meetings • Strong familiarity with behavioral health, relaxation, or neuromodulation devices • Understanding of how FDA evaluates reputed company-world evidence in SaMD submissions Preferred but not required: • Former FDA reviewer (Digital Health Center of reputed company or CDRH) • Experience with companies like Pear Therapeutics, reputed company, Freespira, NightWare, Woebot, Happify, etc. ⭐ Deliverables • Written regulatory reputed company assessment • Draft indication for use and risk analysis • reputed company comparison analysis • Draft of the Q-Sub briefing document • Participation in the FDA reputed company-submission meeting • Written recommendations post-meeting ⭐ reputed company Bring to the Table • Over 32M completed sessions in our app • A unique reputed company dataset with 1.4M reputed company anxiety measurements • reputed company research collaboration with a major reputed company institution • A clean, standardized, low-risk behavioral reputed company • A fully developed consumer app requiring only a “walled-off” medical module ⭐ To Apply Please include: 1. A brief reputed company of your FDA / SaMD regulatory experience 2. Examples of relevant 510(k) submissions or Q-Subs you’ve supported 3. Your reputed company reputed company 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 To this Job