2015 – current INDEPENDENT CONTRACTOR AND CONSULTANT
Specialized in startups and research organizations with expertise in strategic regulatory planning; label and SOP development; OTC, 510(k), IDE, PMA, CE marking (MDD and AIMD) and STED submission development; domestic and international compliance activities; assistance with initiating quality management system; preparation of initial clinical and regulatory documentation; quality and regulatory auditing; state and local registrations; mentor with Life Science Tennessee.
Zyomed Corp Altadena, CA Device (Glucose Monitoring)
PhysioLogic Devices Inc. Alpine, CA Device (Infusion Systems)
Caldera Inc. Agoura Hills, CA Device (Hysteroscopy)
Urologix Inc. Minneapolis, MN Device (Endoscopy)
FormLabs Inc. Boston, MA Device (Resins for 3 D printed devices)
Board of Directors:
Venostent Houston, TX Device (3 D printed cardiac device)
2009 – 2015 DIRECTOR, REGULATORY AFFAIRS – BIOMIMETIC THERAPEUTICS, LLC. FRANKLIN, TN (Division or Wright Medical Technologies)
Director of Regulatory Affairs with submission and compliance responsibilities for Investigational Device and New Drug Applications for Drug/Device combination products regulated as drugs and Class III medical devices. Other responsibilities include quality and regulatory auditing, developing and implementing Domestic and International regulatory strategies, preparing technical and design dossiers, STEDs and other international submissions and import/export documentation; quality and risk management; labeling; complaint handing and product reporting.
Non - regulatory responsibilities: Tennessee State Board of Pharmacy registration and correspondent, Designated Representative to the State of California Board of Pharmacy and manager of the Board of Pharmacy /Verified Accredited Wholesale Distributor program.
2008 – 2009 INDEPENDENT CONTRACTOR AND CONSULTANT, SANTA CLARITA, CA
Specialized in startups and research organizations with expertise in strategic regulatory planning; label and SOP development; 510(k), IDE, PMA, CE marking (MDD and AIMD) and STED submission development; domestic and international compliance activities; assistance with initiating quality management system; preparation of initial clinical and regulatory documentation; quality and regulatory auditing.
MicroChips Inc. Bedford, MA Device (Glucose Sensing)
Infusion Systems LLC. Sylmar, CA Device (Pain Management)
NeruoSystec Inc. Santa Clarita, CA Drug/Device Combination (Tinnitus)
Alfred Mann Foundation Santa Clarita, CA Device Development (Stimulators)
2005 – 2008 MANAGER, REGULATORY AFFAIRS – ALFRED MANN FOUNDATION, SANTA CLARITA, CA
Manger of Regulatory Affairs department of AMF, a research foundation which develops Class III medical devices intended use in muscle and neural stimulation. Responsible for managing, preparing and maintaining investigational device submissions, domestic and international; medical device reporting (complaint handling) and vigilance reporting; device tracking; quality system, and risk management activities; facilities registrations, Good Laboratory Practices and internal quality system auditing; responsible for developing and maintaining clinical documentation for submission. Served as Home Medical Device Exemptee for sister company Bioness.
1996 - 2005 MANAGER, REGULATORY AFFAIRS - MEDTRONIC MINIMED, NORTHRIDGE, CA
Manager of the Regulatory Affairs department of 12 individuals for Medtronic MiniMed, a company which manufactures and distributes Class II and Class III medical devices for use in the treatment of diabetes in the USA and in one-hundred and twenty-nine countries. Responsible for managing, preparing and maintaining investigational and remarket approval submissions for both drugs and devices, domestically and internationally; medical device (complaint handling) and vigilance reporting; device tracking; CE marking; facilities registration and drug and device listing; responsible for clinical drug product releases (Exempt Pharmacist) and implementation of the state of California regulations (home medical device retail and pharmacy requirements). Served as guest auditor for corporate regulatory (2001-2005). Served as RA liaison to Clinical Research and serve as “safety coordinator” for drug related studies.
Simultaneously managed the Clinical Studies unit of 5 individuals in Hollywood Florida. Responsible for manufacture, distribution, and QC of the investigational drug; clinical subject support, licensing of the facility with FDA and the State of Florida, and import export of clinical product to Canada and Mexico.
1995 -1996 REGIONAL PRODUCT MANAGER- COSMETICS, EUROPE AND AFRICA,
HERBALIFE INTERNATIONAL INC., LOS ANGELES CA.
Manager of the International Cosmetics Projects; responsible of international regulatory and submissions activities in the EU, Baltic region and the Near East and Asia.
- SENIOR REGULATORY ANALYST AND SECTION MANAGER, INTERNATIONAL AND DOMESTIC REGULATORY AFFAIRS; ALLERGAN/AMO/IOPTEX RESEARCH INC., IRWINDALE CA/IRVINE CA.
Associate Manager of International Regulatory Affairs, managed a staff of three (IOPTEX, manufacturer of intra-ocular lenses - Class III medical devices formerly a Smith and Nephew Company). Responsible for all the international regulatory activities and CE marking and reported to the VP of Clinical and Regulatory Affairs.
1990-1991 DIRECTOR OF SCIENTIFIC AFFAIRS; LIBBY LABORATORIES, BERKELEY, CA
Director of QA/QC and Regulatory Affairs for a small contract manufacturer of OTC drugs and cosmetics
19881990 INTERNATIONAL REGULATORY ADMINISTRATOR; BAXTER HEALTHCARE, HYLAND BIOTECHNOLOGY DIVISION, GLENDALE, CA
Baxter/Hyland, manufacturer and distributor of Factor VIII, IX and Albumin products, Served as Senior Administrator in international regulatory affairs.
19861988 R&D/CORPORATE MICROBIOLOGIST; REDKEN LABORATORIES, CANOGA PARK, CA
Corporate Microbiologist responsible for plant and water system hygiene and GMPs; preservative efficacy testing, systems formulation and QC microbiology of hair care and cosmetic products.
- R&D/NEW PRODUCT DEVELOPMENT MANAGER; SWAN CUMBERLAND MFG., SMYRNA TN.
New Product Development Manager for an OTC drug and cosmetic contract manufacturer, managed a staff of five, developed OTC analgesic and couch-cold preparations, hair care and personal hygiene products. Customers included Safe Way, Ralph’s and Kroger’s markets.
19781983 RESEARCH ASSISTANT III; DEPARTMENT OF BIOCHEMISTRY, VANDERBILT UNIVERSITY MEDICAL SCHOOL, NASHVILLE, TN
Responsible for the preparation, purification and identification of the microbial toxin associated with Group B Streptococcal Neonatal Respiratory Syndrome. As the senior RA, worked with students and graduate student as Lab Proctor and advisor. Also served as an independent research associate to the Nashville, TN Public Health Department working with Gonorrhea strains.
- VARIOUS TECHNICAL AND LABORATORY POSITIONS IN CHEMISTRY AND MICROBIOLOGY WITH COSMETIC MANUFACTURERS
Formulating and QC chemist, microbiologist and laboratory supervisor for such companies and Revlon, Yardley of London and Lanvin-Charles of the Ritz/Squibb.
- RUTGERS UNIVERSITY, 19651969 – BA (1971) Major: European and Medieval History,
Minor: Biological Sciences & Chemistry, 19731975 Graduate Courses: Industrial Microbiology
- COLOMBIA UNIVERSITY SCHOOL OF PHARMACY 1971-1972 – Certification - Cosmetic Formulation
- UNIVERSITY OF TENNESSEE, 19761978 - BS, Major: Biological Sciences/Microbiology, Chemistry
- VANDERBILT UNIVERSITY SCHOOL OF ALLIED HEALTH, 19791980 - Registered Medical Technologist (ASCP)
- UNIVERSITY OF CALIFORNIA, 1989-1991 - Hazardous Waste Management and Industrial Hygiene
PROFESSIONAL CERTIFICATIONS, LICENCES AND ASSOCIATIONS:
- Designated Representative/Exempt Pharmacist: State of California: 2002-2005, 2010-2015
- Regulatory Affairs Professionals – 1988-Present
- Regulatory Affairs Certified -2000 – 2017 (not renewed)
- American Society for Quality and Biomedical Auditing, Quality Auditing ISO 9001: 2003-2012 (not renewed)
- (1983) Abstract -Society of Pulmonary Medicine, New Orleans - Characteristics of Group B Strep. Toxin (Second Author).
- (1983) Abstract, ASM, Nashville TN - Characteristics of Group B Strep Toxin and worked with other authors.