Caitlyn Dzhafarov
Regulatory Advisor
PROFESSIONAL EXPERIENCE
Extensive experience as a quality and regulatory professional with a diverse product portfolio in the regulated medical devices industry.
Background in quality systems, software quality engineering and regulatory affairs in American and International Markets including EU, Canada, S. Korea, Argentina, Australia, China, Japan, Brazil and Argentina.
Experience in ISO 13485:2016 certification, MDSAP certification, FDA breakthrough device designation, 510(k) clearances, De Novo and CE marking, and have extensive experience developing 513g, presub, BDD, 510(k), De Novo, PMA, HDE, EUA and IDE/HREC submissions, risk management, clinical/ regulatory strategy, quality systems management, product project management, international standards and regulation gap analysis, software classification and validation, GDPR compliance, materials compliance and general manufacturing engineering principals.