Academic Credentials
  • Ph.D., Biomedical Engineering, Tulane University, 1996
  • M.S., Biomedical Engineering, Tulane University, 1992
  • B.S., Biomedical Engineering, Tulane University, 1990
Licenses & Certifications
  • Certified ISO 13485 Medical Device Management Systems Lead Auditor
  • Good Clinical Practices (GCP) in Medical Device Clinical Investigations
  • ISO 14971:2019 - Application of risk management to medical devices
  • Regulatory Affairs Certification (RAC: Devices)
  • Regulatory Affairs Certification (RAC: US)
Additional Education & Training
  • Leading Strategic Growth, Columbia Business School, Executive Education ExecOnline, June 2021
Academic Appointments
  • Research Assistant Professor, School of Biomedical Engineering, Science and Health Systems at Drexel University, Philadelphia
  • Previous Academic Appointments
  • Adjunct Professor in the Department of Mechanical Engineering at Temple University, Philadelphia
  • Visiting Lecturer in Mechanical and Aerospace Engineering at Princeton University, 2000-2006
  • Adjunct Assistant Professor in the Department of Biomedical Engineering at Tulane University, New Orleans
Professional Honors
  • American Association of University Women (AAUW) Selected Professions Fellow
  • National Science Foundation Minority Graduate Fellow
  • Sigma Xi (Scientific Research Society)
  • Alpha Eta Mu Beta (Biomedical Engineering Honor Society)
  • Tau Beta Pi
  • 2000 Harold Levey Award (Tulane School of Engineering: In recognition of professional achievement to an alumn)
Professional Affiliations
  • Regulatory Affairs Professionals Society (member)
  • Women in Bio (member Philadelphia Chapter)
  • MedTech Women (member)
  • ChIPs® (Chiefs in Intellectual Property) (member)
  • Medical Device Innovation Consortium (MDIC), Case for Quality
  • Food and Drug Law Institute (Corporate Member), 2020 & 2021 Annual Meeting Planning Committee, 2023 Enforcement, Compliance and Litigation Planning Committee
  • Orthopaedic Research Society (member)
  • ASTM International (member), Subcommittees F04.25: Spinal Devices, F04.15: Material Test Methods, F04.18: Device Retrieval Analysis
  • Life Sciences PA (Corporate Member), 2019 Life Sciences Future, MedTech Planning Committee
  • The Forum of Executive Women (member), 2021 DEI Committee
  • Philadelphia Biotechnology & Medical Device Seminar Series, Co-Founder 2004
  • Spanish

Dr. Villarraga has expertise in evaluation of medical device performance during the premarketing and postmarketing stages. She has experience with orthopedic, spinal, plastic and reconstructive surgery, urology, urogynecology, general surgery, women's health, and diagnostic medical devices, with particular emphasis on biomechanics and biomaterial-tissue interactions with medical devices. 

Dr. Villarraga has provided technical support for due diligence, regulatory submissions, regulatory compliance, risk management, postmarketing surveillance, product development, product liability, and intellectual property matters. As a Regulatory Affairs Certified (RAC-US, Devices) professional, Dr. Villarraga uses her knowledge of the U.S. FDA regulations to develop regulatory strategies for novel products, contribute or prepare regulatory submissions, and to support identifying and justifying technical evaluations for pre-market assessments and postmarket compliance matters.

Dr. Villarraga has experience in identifying scientifically justifiable methodologies for assessment of medical device performance, evaluating quality control issues as applied to medical devices and pharmaceuticals, medical device quality systems compliance (gap analysis), contamination, manufacturing compliance, and finished device evaluations. Dr. Villarraga has conducted failure analyses, root cause analyses, and compliance evaluations related to medical device recalls. She has served as an expert witness in product liability and intellectual property cases involving medical devices.

Dr. Villarraga's research experience and interests include spine biomechanics, implant and tissue retrieval analysis, including the use of microscopic (SEM) and tissue analysis techniques (ICP, histology), use of animal models for evaluating orthopedic/spinal device performance, and the use of experimental and finite element stress analysis techniques to characterize the mechanical behavior of bone, other biological structures, and orthopedic/spinal implant devices.

Dr. Villarraga has been a reviewer for the Journal of Biomechanical Engineering, Clinical Orthopedics and Related Research, Clinical Biomechanics, Clinical Neurology and Neurosurgery, and the Journal of Biomedical Materials Research.

Recent Projects