HealthTech Regulatory & Compliance Advisor

About the project We are building Phase 3 of a regulated metabolic health platform: AWS backend, mobile apps, sensor/wearable data, deterministic decision engine, LLM used for verbalisation only. Launch is wellness-first, with full SaMD-capable architecture built now and hard server-side gates so medical claims activate only after market approval. Four regions: EU, UK, US, UAE, with health data locked per user region. We need a regulatory and compliance advisor from kickoff/architecture phase through build , working with our XTO. You translate regulatory requirements into clear guidance for engineering, you do not own product roadmap or delivery. What you will do Review build requirements: multi-region residency, wellness vs medical output boundaries, audit/traceability, retention, access controls Advise on wellness/SaMD split: claim gating, output profiles, versioned processors, build-once/activate-later architecture Produce a compliance requirements register and assumptions/exclusions log the build team can use Cover GDPR, UK GDPR, HIPAA (where applicable), UAE PDPL, and cross-border data rules Guide IEC 62304–compatible SDLC evidence and ISO 13485–ready lifecycle posture (traceability, controlled releases, audit logs) — advisory only, not QMS certification or submissions Work with our legal counsel and internal regulatory stakeholders on jurisdictional sign-offs (SCCs, PDPL registration, US data classification, DPIA for analytics features) Join 2–4 calls per week during early architecture/scoping, then ongoing advisory through build What this is not Tech Lead, PM, or engineering role Hands-on coding (helpful if you can read architecture docs and data-flow diagrams) Certification, FDA/MDR/DiGA submissions, or external audit ownership Replacing legal counsel Ideal background 3+ contactable references on regulated digital health: SaMD, DiGA, FDA-cleared, or MDR-equivalent software (not only HIPAA apps using third-party cleared devices) Multi-region delivery with EU + Middle East (UAE/GCC) data residency Experience with wellness → SaMD or build-and-gate product paths Comfortable advising engineers on audit logging, data classification, retention, and deterministic (non-ML) decision systems Bonus: IEC 62304, ISO 14971, 21 CFR Part 11, clinical evaluation / PMS planning Engagement Fractional: ~15–25 hrs/week Duration: architecture phase (~3–4 weeks) + build (~4–5 months) Timezone: overlap with EU business hours preferred Spec shared with shortlisted candidates under confidentiality agreement To apply Two examples of regulated digital-health platforms you advised (your role, jurisdiction, wellness vs medical) Three contactable references (SaMD/DiGA/FDA/MDR context) One multi-region example with EU + Middle East residency — what you specified vs what was built How you would approach early scoping with a Technical Lead on a large fixed-scope build Availability (hrs/week) and rate Short, direct proposals only. Compliance should be designed in from day one, not added at the end.