Consultant
Professional medical device consultant with solid technical and compliance knowledge, skilled in quality systems, process validation, product development and improvement, and regulatory approvals and submissions. Highly credentialed with years of experience in top global U.S., European, and Canadian, medical device manufacturers. Background in capital electro-medical equipment, disposable devices, implants, sterile devices, combination products (drug/device), IVDs and surgical instruments.
CORE COMPETENCIES
- World Wide Regulatory Approvals
- Project Management
- Product Development
- QSR
- Annex II MDD Quality System Certification
- ISO 13485
- CDMR Certification
- FDA and CE Mark
- Procedure Systems/Design History
- Infant Resuscitation
- Process Improvement
- Software Quality Validation
- Risk Management
- JCAHO Certification
- ISO 9001
- EN 46001
- 510 (k) s
- International Standards Development
- cGMP
- TQM
SELECTED ACCOMPLISHMENTS
- Developed product V&V and design history, vender selection and management for worldwide regulatory approval including distribution of Atom Medical Incubators, Warmers and Transports, Infant Resuscitation, Pediatric/Adult Resuscitation systems and accessories
- Participated as key person in divestiture of Air Shields and integration of two organizations and quality systems
- Directed regulatory affairs and quality for North American Ventilator and Anesthesia division, Perinatal Care division, and Monitoring division
- Established all human resource requirements for start up company
- Obtained FDA, CE, and Canadian regulatory approvals for insulin pump, quality system certification and JCAHO accreditation for home use products
- Supported product development of external infusion pump and pre-clinical work on implantable glucose measurement device
- Managed quality department of 5 technicians responsible for all quality assurance and software validation functions
- Supported new product development, validation, verification and documentation of design control processes
- Supported all manufacturing process control and clean room compliance for surgical laser systems, surgical hand instruments and OEM products
- Managed team of 13 engineers and technicians responsible for strategic work for arrhythmia reclassification and international standards development
- Managed team of 7 engineers and technicians in software validation processes for patient monitoring portfolio, GMP compliance, quality system certification to EN46001, and implemented TQM and process improvement
- Managed worldwide regulatory approvals for defibrillators, electrocardiographs, Holter monitoring, and ECG management systems
- Edited diagnostic and Fetal Doppler Ultrasound Guidance for FDA, and was responsible for engineering review of premarket approval applications
PROFESSIONAL EXPERIENCE
- Independent Consultant, (Conshohocken, PA – 1994 to Present
- NeoForce Group, Inc., VP Regulatory, (Warminster, PA) – 2006 to Present
- Hill-Rom Air Shields, Director Regulatory and Quality, (Lancaster, PA) – 2000 to 2006
- Animas Corporation, Director Regulatory and Human Resources, (West Chester, PA) – 1999 to 2000
- Surgical Laser Tech, Director RA/QA, (Montgomeryville, PA) – 1996 to 1999
- Hewlett Packard, Medical Products, Manager, Regulatory Approvals, (Andover, MA) – 1989 to 1996
- Food &Drug Admin., Reviewer, OB/GYN, ENT and Dental Devices, 1987 to 1989
- Bendix Field Engineering, Systems Analyst, (NASA Goddard) – 1985 to 1987
- Capital College, Adjunct Professor, (Laurel, MD) – 1982 to 1985
- Singer Company, Link Div., Lead Engineer, (Silver Spring, MD) – 1980 to 1985
- Modification Systems, Inc., Programmer. (Santa Fe Springs, CA) – 1979 to 1980
EDUCATION
- Doctorate Public Administration, University of Southern California – 8/04
- Masters Public Administration, University of Southern California – 8/03
- M.S. Physiology, Georgetown University, 5/88
- B.S. Biomedical Engineering, Catholic University, 5/79
PUBLICATIONS AND PRESENTATIONS
- 1 Patent Issued, 1 Patent Pending for pediatric/adult resuscitation device
- Guest Lecturer, University of Pennsylvania Center for Technology Transfer, Masters in Translational Research
- Guest Speaker, Small Business, New Technology, and Regulatory Affairs seminars
