Hau N.Private profile: Upwork shows its earnings only to signed-in members, so we check it every few weeks, not daily. MRR here is a rough estimate (Upwork's six-month earnings ÷ months active). Last read Nov 5, 2026.

Regulatory Affairs consultant with 10+ years across medical devices, clinical trials, cosmetics and food supplements. I help manufacturers and brands place products on the EU, UK and Swiss markets with documentation that holds up to authority and notified-body review, and deliverables your team can use straight away. 🩺 Medical Devices & QMS • EU MDR 2017/745 technical documentation (STED, GSPR checklist, ISO 14971 risk management) • ISO 13485 QMS: SOPs, document control, CAPA, audit and inspection readiness • Alignment with 21 CFR 820, UK MHRA and TGA requirements 🧪 Clinical Trials & GCP • ICH-GCP E6(R3) SOP packages, TMF structures, inspection-ready documentation • Ethics and Ministry of Health submissions for 10+ drug/device trials; CRC on Phase II/III trials • Pharmacovigilance support, AE/SAE reporting 💄 Cosmetics (EU Reg. 1223/2009 and UK) • CPSR Part A + B, signed as Safety Assessor; PIF compilation • Label and claims review with copy-ready text; CPNP / SCPN notification 🌿 Food Supplements & Foods • Ingredient, dose and novel food checks before you lock a formula • Label review (FIC 1169/2011, Directive 2002/46/EC, health claims register) • Notifications in Germany (BVL), France (Compl'Alim), Belgium (FOODSUP) and other EU markets 🌍 EU/UK Market Access • EU/UK Responsible Person, Food Business Operator and Authorised Representative services available ✅ Recent work • GCP E6(R3) SOP package for a clinical-trial client (5.0★) • CPSR + 366-page PIF for a UK body scrub, including a nanomaterial assessment • 8/8 supplement labels approved for print for a UK brand entering Germany and France • BVL and Compl'Alim notifications for an ashwagandha supplement; Belgian NUT number for a fortified food How I work: a gap list first, a clear fixed scope, and copy-ready deliverables. MSc Translational Medicine (University of Barcelona), BSc Biotechnology. English, German, Vietnamese.