Tamara S.

I’m a mission-driven Regulatory & Quality Director with a rare cross-functional background spanning FDA and international compliance, digital project management, and tech-enabled product launches.

From 510(k) submissions and EU MDR transitions to Shopify Plus site builds and SaaS platform rollouts, I help brands scale safely and smartly, building systems, streamlining operations, and launching with confidence across industries.

Core Services

🌍 Global Regulatory & Quality Strategy
• FDA: 510(k), eSTAR submissions, OTC monographs, labeling compliance
• EU MDR: Tech files, CER/PMCF, PMS setup
• Health Canada CNFs, bilingual labeling, safe ingredient declarations
• Cosmetic & skincare claims compliance (US/EU/CN/AU)
• Heavy metal, PET, stability testing coordination
• QMS design, validation & SOP buildout (Veeva, MasterControl, Notion, Greenlight Guru)

🧠 Strategic Ops & Project Management
• Digital project management (Asana, Monday.com, Notion, Trello, Jira)
• Shopify Plus, WordPress, and custom e-commerce site management
• Cross-functional team coordination (design, development, QA, marketing)
• Launch roadmaps for DTC brands, wellness clinics, and beauty startups
• Agile delivery + stakeholder reporting (Gantt, KPIs, testing coordination)

💻 Clinic & Wellness Tech Implementation
• Practice Better implementation for wellness clinics & medical spas
• Intake forms, booking flows, automation setup, and digital consent systems
• HIPAA-compliant workflows + client success tracking
• System integrations and training for functional medicine, esthetics, and nutrition brands

📄 Technical Writing & Launch Docs
• 510(k) packets, CERs, QMS procedures
• Grant writing (SBIR, innovation funding)
• Clinical documentation and internal training SOPs
• Label reviews, compliance assessments, and gap audits

Whether you’re launching a cosmetic line in Canada, preparing a device for FDA clearance, building a Shopify site for a global brand, or implementing a system for a wellness clinic; I bring end-to-end project oversight, technical expertise, and clear communication to get you there on time and in full compliance.

Let’s launch something extraordinary and built to last.