A highly skilled professional with over 20 years in the Quality|Regulatory arenas. Opened up world markets using Regulatory Pathway strategies and have obtained the necessary certificates to sell products world wide.Successful Internal and External Audits (ISO 13485 certification, ISO 9001 certification, FDA Approval, MDR)Have implemented Quality Systems in its entirety, mainly in Start-Ups. Has created Document Control Systems, NON-Conformance and CAPA Systems, Audit Systems, Training Systems, Quality Control Systems etc. Directed, guided and implemented quality without the overburdening of quality. I have lead and guided people through the process of performing risk analyses/assessments, change control and product control to help them make sound decisions when making recommendations for the development and improvement of products and processes while ensuring the risk is minimal and acceptable. Worked with vendors and/or suppliers to ensure that both parties come to a mutual understanding of acceptability of assemblies, sub-assemblies, tools, supplies or products.Although My experience is mainly in the Biotech/Pharma industry, I am able to apply the Quality|Regulatory System standards across any industry and across many countries. I have consulted with oil terminals to ensure the Quality|Regulatory Systems were in compliance and to create risk-based solutions. I have consulted with electrical parts manufactures as well.Some Guidelines and Regulations: FDA CFR, ISO/EN, EEC, ICH, MOTEMS, etc.,

Quality Systems and Regulatory Consulting

Manage and enhanced the Quality System through development, implementation and maintenance of quality system procedures and activities in compliance with domestic and international regulations.