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

Regulatory and quality systems specialist with twenty-three years of medical device experience.  Excellent understanding of FDA, European, and Canadian requirements, 510(K) pre-market notifications, supplier quality management, process and software validation, risk management, project management, and statistical process control.

Titles Held: Quality Assurance Manger; Senior Process Engineer; Manager of Control Laboratory; Process Engineer

• Experience Conducting mock FDA inspections and QSR training
• Worked for Start Up companies to large medical device firms
• Managed quality systems registrations for US and European clients ISO 19385/6, CMDCAS
• Management and coordination of recalls and corrections, FDA inspections and related events
• Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA)

Thirty-three years of experience in the medical device and combination drug/device regulation, manufacturing, quality assurance and R & D arenas.  Specialty is working on the pre-meetings and briefings with the FDA.

Titles Held: Corporate Senior Director of RA; Global Director of RA; Director of RA North America; Quality Assurance Manager; Senior Microbiologist

• Has extensive experience in interfacing with the FDA, at the district and headquarters levels, as well as with international regulatory authorities
• Strong international experience including international product registrations, CE mark approvals and import/export activities
• Extensive experience with compliance issues, Warning Letters, product recalls, facility inspections and resulting 483 responses and consent decrees
• Has obtained both PMA’s and 510(k)’s, In-Vitro diagnostics, IND, IDE, PLA and NDA approvals.
• RAC certified with extensive knowledge with combination drugs devices