Seasoned professional with thirteen of years experience in both Domestic and International Regulatory Affairs and Quality Systems. Strong 510(K) submission work and extensive knowledge of implementation of total quality system certifications for the Medical Device industry.

Titles Held: Manager of Quality Assurance and Regulatory Affairs; Senior Quality Engineer; RA Specialist

• Expert in Process and Software Validation; Knowledgable QSR Trainer
• Extensive experience with FDA Inspections and Quality system Audits
• Experience with Class II Intravascular Devices; clinical trials
• Experience working RA and QA systems in the US, EU, Asia Pacific and Latin America; CE Marking experience
• Certifications: RAC, ASQ, CQA, RAB-Certified Lead Quality Auditor

Thirty year veteran in the medical device arena, including thirteen years working for the FDA as engineer/field investigator and supervisor specializing in medical devices. Has worked with a wide range of FDA and international requirements while solving regulatory compliance issues and improving quality systems.

Titles Held: Director of Quality Assurance; Manager of Regulatory Compliance; Manager of Quality Assurance Engineering; Associate Manager of QA Engineering

• Well experienced in FDA issues including remediation of FDA-483 observations, warning letters, recalls, and consent decrees
• Has conducted medical device quality system compliance (QSR and/or ISO 13485) audits in Canada, China, Puerto Rico, Ireland, England, Germany, EU, and Mexico
• Resolved large backlog of medical device complaints, risk analysis, and investigations
• Managed remediation programs and resolved non-compliance issues leading to ISO certification and PMA & 510k approvals
• Experienced with multi-facility corporate quality assurance and regulatory compliance programs