Susanne T.

Smith, MS
1532 Raphis Royale Blvd.
Englewood, FL 34223
(941) 460-8849 (office)
(941) 460-8852 (FAX)
ss2970fe@westpost.net (e-mail)
PROFESSIONAL EXPERIENCE
2003-present Clinical and Regulatory Affairs Consultant for medical product comp
anies developing medical devices
[recombinant collagen for dermal filling],[xenograft for ACL reconstruction], [b
one void fillers],
orthobiologics [PDGF grafts for distal radius fractures], combination products [
recombinant collagen],
and biological products [chondroplast articular knee graft], medical writing for
protocols, reports, &
operating procedures. Obtained IDE approval, CE Mark approval, Australian and Ca
nadian device
approvals. IND approvals for Phase I/II pilot studies for combination products.
2001 to 2003 Revivant Corporation Sunnyvale, CA CPR and Emergency Medicine
Vice President, Clinical & Regulatory Affairs for a small medical device company
focused on emergency medical medicine (EMS) to perform automated, mechanical ca
rdiac compressions for pre-hospital cardiac arrests victims. Focused on developi
ng & establishing new relationships with the EMS medical directors and end-user
community EMS providers with collaborative county authoritative agencies/city re
presentatives to field test a 510K preamendment Class III medical device, partic
ipate in randomized pilot studies, and/or future marketing studies; received IRB
proposals. Reviewed and edited all engineering change orders (DCOas), marketing
promotions and literature, & wrote/edited quality/departmental SOPas. Filed Med
ical Device Reports (MDR) & investigated patient-related complaints or adverse e
vents. Collaborated with Quality, & R & D with subsequent receipts of ISO certif
ication, FDA State & Federal Premarket facility inspection audits, filed & recei
ved Special 510K, and Technical File for European CE marking, and future Austral
ian listing. Communicated with Canadian Ministry of Health and Japanese regulato
ry attorney in preparation for regulatory filings for commercial distribution &/
or clinical assessments.
1998 to 2001 Independent Clinical and Regulatory Consultant
Class II and Class III critical medical devices, Phase I/II biological safety &
dosing studies; Cosmetic and GMP regulations. Experienced in cardiology, trauma/
orthopaedics, laser therapy, interventional neuroradiology, ovarian and breast c
ancer (in vitro diagnostics), urology, dental and oral maxillofacial surgery, co
llagen immunology, dermatology/plastic surgery, & tissue engineering for medical
devices.
1993 -1998 Norian Corporation Cupertino, CA Orthopaedic Trauma and Craniofacial
Applications
Vice President, Clinical & Regulatory Affairs for an orthopaedic medical device
company focused on trauma and osteoporotic fractures. Responsible for all clinic
al research & regulatory submissions (IDE(s), PMAA [Norian SRS], 510K [Norian CR
S]) domestic & international (Canadian & CE Mark), and European post-marketing s
urveillance. Committee Chairperson for Japanese joint venture partner to develop
clinical strategy and trial initiation in Japan. Meet with FDA to review regula
tory strategy and study design before multicenter clinical study commencement. D
evelop documents for regulatory submittals, Investigator Brochures, & received F
DA approval to commence feasibility and randomized multicenter trials. Received
Administrative PMAA approval for Class III orthopedic device. Develop and negoti
ate budgets and contracts, strategize and identify financial data to establish r
eimbursement or cost-effectiveness studies, write/edit protocols, hire, and dire
ct clinical/regulatory personnel on a worldwide basis. Met with European regulat
ors in preparation of Medical Device Directives (Economic Community) and medical
device registration (CE Mark). Write technical monographs/white papers, draft p
ublications, meet with venture capitalists and present clinical applications and
data to outside agencies. Ongoing communication with Marketing, Finance, Engine
ering, and R & D members; report to the CEO and Board of Directors.
1991-1992 Triton Diagnostics, Inc. Alameda, CA In Vitro Diagnostics (IVD) for Ca
ncer
Manager, Clinical Research for a small in vitro diagnostic company. Responsible
for clinical research budgets, initiate Class III feasibility clinical trials fo
r ovarian and breast cancer for PMAA approval. Designed clinical data base for s
tatistical analysis, recruit investigators, negotiate contracts, IRB approvals,
protocol design and the writing of regulatory reports. Interacted with Marketing
, and Project Managers for multiple projects, Shell Oil's Legal Consultant for c
ontract negotiation. Reorganized Specimen Bank to increase efficiency while resp
onsible for the management and collection of clinical specimens within R & D; ch
air the Research Collaboration Committee comprised of Marketing and R & D scient
ists. Company acquired by CIBA Corning Diagnostics.
1991 Urosystems, Inc. Sunnyvale, CA Urological indications-stress incontinence
Director, Clinical Affairs for a start-up company incorporated in 1988. Develope
d and responsible for research budget, ensure regulatory compliance for future P
MAA filing, managed clinical database, identify and categorize subjects to gener
ate monthly reports, met with FDA Inspector as part of a strategic team, hired,
oriented, & organized a staff of 4, audited the clinical department for FDA and
facility inspection, conducted field audits. Managed seven domestic and seven in
ternational clinical sites. Continued funding not available and the technology w
as acquired by Medtronic, Inc.
1989-1991 Target Therapeutics, Inc. San Jose, CA Interventional neuroradiology &
peripheral radiology
Director of Clinical Research/Acting Regulatory Affairs Responsible for the deve
lopment and management of clinical trials in compliance with the Investigational
Device Regulations (IDE), Medical Device Reporting (MDR/GMP), annual reports, d
atabase development, and commercial product evaluations for regulatory filings.
Interacted with management and FDA during the writing and development of Premark
et Notification (510K) and IDE(s). Trained CRA's to monitor trials according to
GCP(s) and perform internal audits. Collaborated with research engineers on mult
iple projects during product development to clinical trials or commercialization
. Developed and revised Standard Operating Procedures (SOP) in collaboration wit
h Quality Assurance. Developed budgets & contracted with appropriate consultants
. Wrote and submitted international submissions for research and registrations w
ith subsequent approvals.
1988-1989 Advanced Biosearch Associates Danville, CA Clinical and regulatory con
sultant
Director, Clinical Research Responsible for the management of a clinical researc
h department, staff of 5-7 members, generated budgets and client proposals, trai
ned clinical monitors for field audits according to GCP(s). Project director of
multiple contracted client activities that involved the development & management
 of various clinical trials, writing of protocols, annual reports, and documents
for regulatory submissions. Drafted a laser Premarket Notification (510 K) with
supporting clinical data acquired under an IDE, received subsequent FDA clearan
ce. Participated in the writing of IDE(s), device reclassification of a transiti
on device, attended and prepared experts' presentations for FDA panel meetings.
1984-1988 Collagen Corporation Palo Alto, CA Dermatology & Plastic Surgery, Oral
Surgery, & Orthopaedics
Clinical Research Associate (Senior) Responsible for writing protocols, interact
ed with IRB(s), monitoring multiple clinical studies domestically and in Canada,
wrote regulatory status reports for internal communication, reviewed statistica
l data, identify experts for contractual work and negotiate contracts, prepared
and monitored study budgets, oriented/educated new clinical monitors, research a
ssistants, and regulatory affairs personnel, wrote and updated SOP(s), wrote saf
ety section for PMAA Submission, attended FDA Panel meeting as clinical resource
, strong involvement with departmental personnel for the dissemination and revie
w of clinical and product labeling, formally train sales personnel, and represen
ted Medical Affairs at sales and medical meetings. PMAA approval for Alveoform f
or alveolar ridge augmentation; company clinical representative and collaborated
with Zimmer on IDE study for Collagraft.
1984-1985 Collagen Corporation Post-Market Surveillance
Medical Monitor Collected and monitored data for complaint files and adverse rea
ctions Zyderm, analyzed data for FDA reports, completed Phase IV monitoring, des
igned report forms for data entry and computerized reports, oriented new Monitor
s and sales personnel to safety profile of commercialized products, maintained c
omplaint files for potential product liability action and collaborate with the D
irector, Quality Control, met with FDA Investigators during complaint file audit
s, prepared and monitored budget, educated physicians as customers and their pat
ientas about the immunological response to bovine collagen implant.
1979-1980 Balboa Naval Hospital San Diego, CA Research Nurse
Shock/Multisystem-Trauma Research Unit
1977-1979 Donald N. Sharp San Diego, CA Head Nurse Recovery Room: 10 bed unit197
1-76 Long Beach Naval and Balboa Naval Hospitals CA Head Nurse Lieutenant Navy N
urse Corps: Recovery Room 21 beds unit; float critical care
Lieutenant Navy Nurse Corps: Head Nurse of Medical ICU and CCU, 15 beds, managed
10 military nurses, 8-12 corpsmen, and additional civilian personnel with 24-ho
ur accountability.
Military Status: Lieutenant Commander (LCDR)Navy Nurse Corp Permanent Inactive
EDUCATION
George Mason University Fairfax, VA 1982-83 Masters of Science-Administration Ma
rymount College of Virginia Arlington, VA Bachelor of Science in Nursing 1980-82
University of San Diego, CA & St. Francis School of Nursing New Jersey
Honors Cum Laude Marymount College of Virginia;
President's Cup for outstanding performance;
Sales and Marketing award for outstanding clinical performance
PUBLICATIONS
Reactions to Injectable Collagen: Results in Animal Models and Clinical Use. F.
De Lustro, S. T. Smith, J. Sundsmo, et al Plastic and Reconstructive Surgery: Ap
ril 1987, 79, 581-592.
Evaluation of Collagen/Hydroxylapatite for Augmenting Deficient Alveolar Ridges:
A Preliminary Report. D. Mehlisch,
T. Taylor, D. Leibold, R. Hiatt, D. Waite, P. Waite, D. Laskin, S. T. Smith, & M
. Koretz J Oral & Maxillofac Surg, 1987, 45, 408-413.
Collagen/Hydroxylapatite for Augmenting Deficient Alveolar Ridges: 12 Month Resu
lts. D. Mehlisch, T. Taylor, D. Leibold, R. Hiatt, D. Waite, P. Waite, D. Laskin
, S. T. Smith J Oral & Maxillofac Surg, 1988, 46, 839-843.
A Process for the In Situ Formation of the Mineral Phase of Bone. B. Constantz,
I. Ison, M. Fulmer, R. Poser, S. T. Smith,
M. Van Wagoner, J. Ross, S. Goldstein, J. Jupiter, D. Rosenthal Science , 1995,
267, 1796-1799.
Repair of Five Distal Radius Fractures with Investigational Cancellous Bone Ceme
nt: A Preliminary Report. J. Jupiter,
S. Winters, S. Sigman, C. Lowe, C. Pappas, A. Ladd, M. Van Wagoner, S. T. Smith.
Journal of Orthopaedic Trauma, 1997, 2,110-116.
Bioactive Materials in Orthopaedic Surgery-Overview and Regulatory Consideration
s. Bauer, T & S. T. Smith, Current Orthopaedics and Related Research, Vol. 395,
pp 11-22, February 2002.
PRESENTATIONS Guest speaker: Northern California Pharmaceutical Discussion Group
4/12/88; Women in Science Palo Alto, CA 9/88
Military Status: Lieutenant Commander (LCDR) US Navy Nurse Corps (Permanently In
active)
CONTINUING EDUCATION
Good Clinical Practices 4/14-16/86, Preparing Clinical Protocols & Managing Clin
ical Investigations 3/88 Regulatory Compliance GMP/QA/QC/SOP 11/14-18/88, Proces
s Validation 10/89 Good Manufacturing Practices (GMPs) 4/90; FDA Medical Worksho
ps GMP/Sterile Devices 6/13-14/90; FDA Workshop In Vitro Diagnostic Devices 6/21
/90; Drugs & Devices 1991: Current Regulatory Issues 11/7-8/91; Registration of
Medical Devices in Europe 7/20-22/92 Good Manufacturing Practices/Preproduction
Quality Assurance 11/13/92, Regulation & Reimbursement of Medical Devices 6/15/9
3; Designing Clinical Trials for Approval & Reimbursement 4/18-19/94; European R
egistration System for Medical Implants (Holland) 6/2-3/94, Reimbursement Planni
ng & Technology Assessment for Devices 12/5-7/94 Current Good Manufacturing Prac
tice (QSR) for Medical Devices 3/5-7/01; Combination Products 3/25-26/04, RAPS 2
004 Western Symposium (International Regulatory and new standards), Technology T
ransfer for Emerging Technologies 5/29-31/07, Medical Device Congress /26-28/08,
American Orthopaedic Association of Sports Medicine July 10-13, 2008, RAPS Hori
zons 3/30-4/3/09, Florida Manufactureras Medical Device 4/7-8/09, & RAPS Annual
Meeting 9/13-16/09DA Clinical Trial Requirements Regulations, Compliance and Goo
d Clinical Practices (GCP) 11/4/5/2010 .
PROFESSIONAL ORGANIZATIONS
Regulatory Affairs Professional Society (RAPS), Society for Clinical Trials, Soc
iety of Clinical Research Associates (SoCRA.