Nineteen years of direct hands-on experience in Class I/II/III medical devices and In-Vitro diagnostics.   Extensive experience in Pharmaceutical and Biologic operations in the areas of regulatory affairs, compliance, validation and quality systems to ensure compliance with FDA and international regulations.

Titles Held: Director of FDA Regulations and Compliance; Corporate Director of Technical and Regulatory Compliance; Corporate Manager of QA/RA; Manager of Quality Engineering

• Expertise in executing process validation, remediation, supplier qualification, training, internal/due diligence audits and policy/procedure development
• Skilled in Risk Management/Assessment; ISO 9001/13485/14971; MDR/AE/product complaints and CAPA’s
• International experience in Japan, EU and Canada regulatory bodies/agencies; also MDD 93/42/EEC and CE Mark and Notified Bodies
• Experience with PMA’s, IDE’s, 510(k)’s, NDA’s and e-CTD/CMCs submissions
• Knowledge with inspection readiness for manufacturers