Confidential mandate
Digital Therapeutics Regulatory Roadmap Director — Consulting
Planned Hiring / New
A healthcare venture commissions a twelve-week regulatory and clinical-evidence roadmap for a digital therapeutic before beginning pivotal validation, market access and technology scale-up across priority markets.
The mandate
The problem is a mismatch among intended clinical claims, present evidence and the regulatory routes implied by target markets. Product development is progressing without one agreed evidence sequence.
The deliverable is a target-product profile, claim-evidence matrix, jurisdiction pathway comparison, pivotal-validation concept, quality and software gap register, market-access evidence plan and board roadmap.
Milestone one arrives 25 September 2026 with claim and evidence baseline; milestone two on 30 October with pathway options and study concept; milestone three on 27 November with integrated roadmap, budget ranges and decision gates.
The Product Evidence Committee accepts when every proposed claim maps to evidence and intended use, legal and clinical reviewers agree the recommended pathway, study endpoints are measurable, and quality gaps have costed owners and dates.
The venture provides source code documentation, product requirements, prior studies, usability evidence, risk files, target-market assumptions and access to clinical investigators. The Chief Medical Officer makes claim decisions within two working days.
Why this is external work
The team has product and clinical depth but not multi-jurisdiction digital-therapeutic pathway experience. Independence is needed to narrow claims before sunk development cost grows. The engagement supplies a finite evidence architecture, not ongoing regulatory representation.
What you will own
- Reconcile intended use, user population, claims and current evidence for milestone one.
- Identify claim gaps that require narrowing, new data or redesigned product behaviour.
- Compare regulatory and quality implications across agreed priority jurisdictions.
- Design a pivotal-validation concept with endpoints, comparator and follow-up logic.
- Map market-access questions to clinical and health-economic evidence.
- Cost and sequence quality, software and study dependencies.
- Deliver the milestone-three board roadmap with go, narrow and stop gates.
Candidate qualifications
- 18–22 years in digital health, medical-device regulatory, clinical development or evidence strategy.
- Direct experience taking a software-based therapeutic or diagnostic through formal validation.
- Ability to connect product claims with study, quality and software evidence.
- Multi-jurisdiction pathway assessment experience.
- Evidence of narrowing a commercial claim to create an executable regulatory route.
- Independence from contract research organisations likely to bid for the study.
Non-negotiables
- No downstream study-placement commission or regulatory-agent retainer bundled into the fee.
- Claim decisions documented by the Chief Medical Officer before roadmap lock.
- Delhi NCR presence for all three committee reviews.
- All conclusions traceable to supplied evidence and stated assumptions.
- 49 words maximum. Which digital therapeutic or software device roadmap did you deliver, and what claim did evidence force you to narrow?
- 49 words maximum. How would you connect intended use, endpoints and regulatory pathway during the first milestone?
- 49 words maximum. Which product, clinical and quality artefacts must be complete before week two?
This mandate is confidential. The client is named only under a mutual NDA, and your own record is never listed, sold or shown to a company under your name until you release it for this specific mandate.