Loma Linda, CA
REGULATORY AFFAIRS CONSULTANT / ADVISOR
Over twenty years regulatory affairs experience involving - International Submissions, Japanese (MHLW), Australian (TGA), Canadian (GMDR), and EU (MDD/2007/47/EC CE MARK Regulatory compliance for March 2010: USABILITY Specification, Validation & Remediation, Software Life Cycle compliance for Technical Files, Engineering Dossier, International Submission (European Communities (EC), Japan, Australia, & Latin America), In-Vitro Diagnostic (IVD) submissions, Risk Management Reporting, Declaration of Conformance - Medical Device Reporting (MDR), Regulatory Management Review, Formal Customer Complaints, Safety Related Investigations, Recalls / Field Corrections - Investigations/Hazard Analysis, Recalls - Coordination, Supplier Quality Investigation, Engineering Change Approvals - Regulatory Implications, Software Change Orders - Regulatory Implications, Risk Analysis - New Product - FMEA (Use FMEA, Design FMEA, & Process FMEA), CRBA
Regulatory Affairs Consultant
October 2004 to Present
FDA Regulatory Compliance & Quality Consulting services - Manufacturing Processes.
(Medical Devices - Class I & Class II)
Quality Management Consultant
1995 to Present
The following positions were Consulting Services in Regulatory Compliance / FDA Submissions / Quality Assurance / Internal Audit: * ConMed Linvatec, Corporate Headquarter - Largo, Florida
Technical Files updates for new MDD CE mark Regulatory Compliance for March 2010 enforcement.
* ConMed Linvatec - Endoscopy - Goleta, California
Regulatory advisor / reviewer on Software Verification / Validation, System / Hardware & Firmware - Design Control Process - meet Regulatory Compliance with Harmonized Standards & FDA Requirements.
* Watson Pharmaceuticals Inc., Corona, California
Software Verification & Validation - Regulatory Affairs - Electronic Controlled Technical Document (eCTD) - software application - approved electronic Drug Application submission.
* Boston Scientific, Fremont, California
MDD Recertification of Peripheral Vascular Imaging Catheters for CE Mark - Design Dossiers and Technical Files to support regulatory compliance - Risk Management - Risk Analysis - Use FMEA - Design FMEA - Process FMEA - Clinical Risk & Benefit Analysis (CRBA) - Gap Analysis - Design Verification Trace Matrix - EN ISO 14971
(Medical devices - Class 1, Class II & Class Iii)
● Beckman Coulter, Inc., Corporate Headquarter - Fullerton, California
Internal Audit & Testing - Mainframe Application Software - Account Payable, Purchasing, Account Receivables, Reports and SAS 70 Audit encompassing Information Security, Application Maintenance & Change Control, Problem Management and , Error Handling/Interface, Contingency and Recovery. Tool used: Teammate Suite (Price & Waterhouse & Cooper) (KPMG) (Medical Devices - Class I & Class II)
● OSI Systems, Inc. Corporate Division - Hawthorne, California
Overseas Compliance & Testing - Consulting assignment
Opto Sensors Malaysia, Johor Bahru, Malaysia - SOX Internal Control Testing, Compliance assessment and remediation (Policy & Procedures), ERP Application, Infrastructure (Network Topography) and Operating Systems Security / Change Control Management / Access Control Management Testing and Remediation.
Dolphin Medical Pte Ltd / Rapiscan Systems Pte Ltd., Singapore - ERP Application and Infrastructure Security / Change Control Management, Access Control Management Testing & Remediation. Tool used: Deloitte & Touche Checklist (Medical Devices - Class I & Class II)
Global Research & Development Informatics - US West
October 2003 to October 2004
Provides Regulatory Compliance (Internal Consulting - Quality Management & Validation) oversight on all software applications including internal audits (Laboratory Instrumentations & Clinical Studies) adhering to the appropriate Regulations (GMP / GLP / GCP / Sarbanes-Oxley) Internal Control Assessment, Business Process Diagram, Information Protection Plan (Inventory, gap analysis & remediation), Internal Control Documentation & Testing, Internal Audit, & documentation of test results.
(Drug Research & Development - NDA )
Drug Research & Development - NDA& INDA
April 2003 to June 2003
Corona, CA - Apr 03 to June 03
SAP R/3 - Quest ERP Validation of Plant Maintenance (PM), Financial/Control (FICO) & Human Resources (HR) Modules - Computer System Validation; URS, FRS, IQ, OQ, PQ, Internal Control Assessment, Internal Audit, Accounting Policy & Procedures and Report Development. (Drug Research & Development - NDA& INDA)
Established / Lead / Executed Test Protocols
March 2001 to March 2003
a JOHNSON & JOHNSON Co, Milpitas, CA - Mar 01 to Mar 03
In-Vitro Device (IVD) Monitoring Systems Validation of Blood Glucose & Anticoagulant Instruments - Class I & II Medical Device and Reagents (Enzymes). Established / Lead / Executed Test Protocols, Test Cases, Test Data Analysis, Calculation/Interpretation of Test Data, Excel Spreadsheet Generation, Simulation Modeling, Summary Report writing for PQ Studies, Internal Control Review/Modification. (Medical Devices - Class 1, Class II & Class III and Biologic Licensing)
March 2000 to February 2001
Irvine, CA - Mar 00 - Feb. 01
Cardio-Vascular Surgical Instrument for Transmyocardial Revascularization (TMR) using Excimer Laser System and Disposable Fiber-optic Hand piece - Class III Medical Device. Performance Qualification - Clinical Study - Phase I - Bench Testing & Phase II Animal Modeling, (Medical Devices - Class1, Class II & Class III)
September 1999 to February 2000
Cardio-Vascular - Catheter Drug Delivery Systems - Class II/III Medical Device Disposables Performance Qualification - Radio Frequency (RF) & Drug Delivery Catheter Systems - Clinical Studies - Phase I, and Phase II. (Medical Devices - Class I, Class II & Class III)
Established / Lead / Executed Test Protocols, Test Cases
April 1999 to September 1999
Pleasanton, CA, April 1999 to Sept. 1999.
Urological Surgical Instruments - Radio Frequency (RF) Non-invasive Surgical System -Female Incontinent - Class II & III Medical Devices and Disposables
Performance Qualification - Simulation Model using Fresh Animal Livers for efficacy tests. Established / Lead / Executed Test Protocols, Test Cases (Hardware & Software), IEC 60601 Electrical Safety & EMC Compliance Testing. Established Design / Performance Trace Matrix to Performance Qualification Tests Prepared / Executed Software System Design Requirements, Software Verification & Validation - Black Box & White Box Approach and Final Reports. (Medical Devices - Class I, Class II, & Class III)
January 1998 to March 1999
Lake Forest, CA, January 1998 to March 1999
IVD - Diagnostic Test Kits - Class II Devices & Biological Reagents Drug-of-Abuse and Alcohol Diagnostic Test Kits for ON-Site Testing - Biotech Disposable Diagnostic Kits
Process Validation of Multi-million Dollars Process Automation System for TesTcup5 Diagnostic Test Kit (Roche) and other Peripheral Process Equipment Established / Lead / Executed (Test Protocols / Test Cases / Final Reports) Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Computer Qualification (CQ). (Medical Devices - Class I & Class II)
October 1997 to December 1997
Ontological Therapeutic Treatment System - Breast Cancer - Class III Device encompassing Instrument / Drug / Disposables - Clinical Trial - Pre-Market Approval (PMA) Phase II. Reviewed / Commented / Organized European Engineering Dossier Filing for Medical Device Directives (MDD) and CE Mark for Agency Submission and Commercialization. (Medical Devices - Class II & Class III and Biologic Licensing)
April 1997 to September 1997
Respiratory - Oxygen Sensors and Monitor Systems - Class II Devices - Instruments and Disposables for CE Mark and European Commercialization
Reviewed / Updated / Organized Product Lines Engineering Dossier Filing for Agency Submission and Commercialization to the European Union (EU). (Medical Devices - Class I, Class II & Class III)
October 1996 to March 1997
Respiratory - Infant Ventilators & Hyper baric Chambers - Class II Devices - Equipment and Disposables - Design & Performance Validation of the Next Generation Infant Ventilator & Hyper baric Chamber. (Medical Devices - Class I, Class II)
January 1996 to September 1996
Respiratory - Adult Ventilators, Monitors, & Disposables - Class II Devices - Equipment and Disposables - Annual Product Line - Performance Validation
Prepared / Executed Test Protocols and Test Cases for OQ & PQ on Electronics Sub-Systems, Process Equipment Calibrations, Operator's Training Records, Preventive Maintenance Records, Statistical Process Control (SPC) Data Analysis and Trends.
(Medical Devices - Class I, Class II)
December 1995 to January 1996
Respiratory - Inhalation Fluid (Aseptic Preparation) and Plastics Disposables - Class I & II Devices - International Product Registration - Minister of Health Agencies Prepared / Gathered / Organized - Medical Product Dossier encompassing FDA Product Approvals & Export License. (Medical Devices - Class I & Class II)
Ph.D. in Advanced Manufacturing Technology
MBA in Program
Business Administration, Finance, Real Estate and Law Department