Dana S.

I’m a Quality Assurance and Regulatory Affairs professional with over 7 years of experience leading compliance for Class I and II medical devices marketed in 20+ countries across North America, the EU, Asia-Pacific, and Latin America. I specialize in building and maintaining globally compliant quality systems and managing regulatory submissions that open new markets while keeping products in compliance. My work spans FDA 510(k) submissions, EU MDR Technical Documentation, and Rest of World (RoW) registrations — including Canada, Australia, Japan, Taiwan, Malaysia, South Korea and others. Clients appreciate my ability to translate global regulations into clear, actionable plans that teams can execute with confidence and precision. CORE EXPERTISE Regulatory & Quality Systems: FDA cGMP, ISO 13485, MDSAP, CE Mark, 510(k), PRRC responsibilities, global regulatory strategy International Market Access: Global product registrations and RoW approvals. Regulatory Submissions: 510(k), EU MDR Technical Files, Clinical Evaluation Reports (CER/CEP), PMS/PMPF, risk management documentation Quality Management: CAPA, internal audits, supplier qualification, and process validation (21 CFR Part 11, CSV) Audits & Inspections: FDA, Notified Body, MDSAP, and global authority audits with zero major findings Leadership & Training: QMS implementation, internal auditor training, and cross-functional compliance alignment WHAT I OFFER ON UPWORK # FDA 510(k) and EU MDR Technical Documentation support # RoW submissions and international registration strategy # ISO 13485 / MDSAP / EU MDR gap analysis and audit readiness # QMS documentation development, SOP writing, and process improvement # CAPA, risk management (ISO 14971), and post-market surveillance planning # PRRC and Management Representative services GLOBAL IMPACT Throughout my career, I’ve contributed to the successful registration and market access of medical devices in over 20 countries, collaborating closely with distributors, regulatory agencies, and notified bodies. I’m passionate about enabling innovation through compliance — ensuring that high-quality, safe medical devices reach patients worldwide.