**** – Present MILLER & ASSOCIATES, Hagerstown, MD.
Regulatory/Clinical Affairs Consultant
Responsible for comprehensive clinical requirements for Phase I through Phase IV clinical trials for medical devices & pharmaceuticals to include qualification/initiation, monitoring and overall management of clinical studies. Duties include writing and verifying clinical investaigation plans and final data management with presentation to FDA and international regulatory bodies. Responsible for clinical section of regulatory submissions and technical dossiers. Areas of specialty are cardiology, neurology, oncology, chronic wound healing, dental,ophthalmics and in vitro diagnostics.
2008 - 2012 University of California – Irvine Extension
Instructor – Clinical Trials Project Management Graduate Course
2007 – 2008 PROMEDICA INTERNATIONAL, Costa Mesa, CA.
Responsible for implementation, management and monitoring of clinical studies for ophthalmic, mammary implant and in-vitro diagnostic industries from inception to completion. Responsibilities include tracking and reporting of clinical screening data as well as subject safety and efficacy data to completion of study protocol. Organize meetings and teleconferences for subject compliance and data safety and efficacy outcomes. Tracks financial status against original statement of work. Wrote clinical SOP’s as required. Served as liaison with FDA and other regulatory agencies, along with technical document preparation and submission, GCP auditing and monitoring of clinical studies.
2002 – 2007 MILLER & ASSOCIATES, Mission Viejo, CA.
Regulatory/Clinical Affairs Consultant
Regulatory and Clinical Affairs Consultant. Responsible for Regulatory and Clinical requirements for Phase I through Phase IV clinical trials for medical devices & pharmaceuticals. Responsibilities include initiation, monitoring and management of clinical studies and, writing clinical sections for 510(k)’s, PMA’s and NDA’s. Areas of specialty are cardiology, neurology, chronic wound healing, dental, ophthalmics and in vitro diagnostics
2000 – 2001 CARDIAC SCIENCE, INC., Irvine, CA.
Director, Regulatory Affairs
Responsible for regulatory management for a start-up cardiovascular company to include FDA and international product submissions and registrations, acquisition of an additional international technology, QSR/ISO internal/external auditing and the management of the Documentation Control Center.
1998 – 2000 NEWPORT MEDICAL INSTRUMENTS, Newport Beach, CA.
Director, Regulatory Affairs/Quality Assurance
Departmental direct reports were Regulatory Affairs, Quality Assurance/Quality Control, and Document Control departments. Responsibilities include all facets of FDA and international agency product submissions and communications, internal and external auditing, and all quality system regulations ISO 13485 & FDA Quality System Requirements.
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1996 - 1997 SORIN BIOMEDICAL, Irvine, CA.
Manager, Clinical and Regulatory Affairs
Responsible for compliance and implementation of FDA/ISO requirements for Class II and Class III cardiovascular and cardiopulmonary medical devices including management and monitoring of clinical trials for both domestic and European manufactured product lines. Member of CE Mark, ISO/EN Advisory Team, Internal Validation Review Committee. Direct reports were the Regulatory Affairs, Documentation, Labeling and Compliance Administration departments. Member of the HIMA Reclassification Task Force for Pulsitile Flow Generators and Centrifugal Pumps.
1994 - 1996 TOKOS MEDICAL CORPORATION, Irvine, CA.
Manager, Regulatory Affairs and Documentation Control
Responsible for Regulatory Affairs and Documentation Control departments for obstetrics medical devices which included internal and external auditing, GMP Compliance, PMA and 510(k) product submissions on Class II and III medical devices, product complaint management, product development assessment, FDA audit contact, management and monitoring of clinical studies and documentation control.
1991 - 1994 BAXTER HEALTHCARE CORPORATION, Irvine, CA.
Senior Clinical Affairs Specialist
Responsible for the domestic and international regulatory and clinical requirements for Class II and Class III cardiovascular product lines in reference to PMA and 510(k) submissions, internal regulatory requirements, clinical trails, and post market surveillance. Responsible for direct communication with FDA medical reviewers and clinical investigators at major institutions throughout the United States and international countries. Member of International ISO Conformance Team.
1988 - 1991 RETROPERFUSION SYSTEMS, INC., Costa Mesa, CA.
Senior Clinical/Regulatory Associate
Responsible for the clinical and regulatory requirements for the development of a Class III cardiovascular system in reference to IDE/PMA submissions, management and monitoring of clinical trials and all internal regulatory requirements. Responsibilities included direct communication with FDA medical reviewers, FDA panel review presentations and management and monitoring of clinical studies at major institutions throughout the United States and Europe.
1986 - 1988 PHARMAKINETICS LABORATORIES, INC., Baltimore, MD.
Product Manager, Contract Product Development
Responsible for management and monitoring of clinical studies for Phase II and III pharmaceutical clinical trials. Responsible for management and monitoring clinical studies, along with final preparation of clinical trial safety and effectiveness reports for NDA regulatory submissions. Also served as a Product Manager for Phase I bioavailability clinical studies.
1977 - 1985 ABBOTT LABORATORIES, INC., Austin, TX.
Product Sterilization Engineer
Responsible for installation and process validation of high volume batch sterilization systems and biological laboratory systems in a large volume parenteral start-up facility. Responsibilities included establishing and implementing installation and process validation protocols, technical writing, sterilization NDA submissions, and FDA presentations. Supervised five engineering technicians. Received Presidential Award for outstanding performance..
Education University of North Carolina
Bachelor of Science Degree
School of Medical Billing,
Professional Career Development Institute
Medical Billing Degree
Professional Member - Regulatory Affairs Professional Society (RAPS)
Memberships Member - Orange County Regulatory Affairs Discussion Group (OCRA)