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