ELENA CURTI
Washington,DC
Summary
Accomplished Regulatory Scientist and FDA Reviewer with over 20 years in medical devices, IVDs, SaMD, digital health, vaccines, Biologics, and pharmaceutical quality. Skilled in translating scientific and cybersecurity evidence into risk-based regulatory decisions for FDA premarket and post-market review. Led multidisciplinary reviews and engaged stakeholders across government, industry, and academia while applying FDA regulations and international standards to enhance healthcare technologies.
Overview
15
15
years of professional experience
Work History
Reviewer | Post-Market Quality, Cybersecurity, Diagnostics & Digital Health SME
U.S. Food and Drug Administration (FDA)
Silver Spring, MD
01.2021 - Current
- Review complex pre- and post-market submissions including PMAs, 510(k)s, De Novo, Q-Subs, PMA annual reports for in vitro diagnostics, software-enabled medical devices, digital health technologies, and connected medical devices.
- Conducted risk-based regulatory assessments of software documentation and cybersecurity measures, including vulnerability management, threat modeling, and penetration testing, to ensure compliance and enhance device safety.
- Collaborated across FDA centers and offices on complex submissions, providing subject matter expertise in cybersecurity and digital health to support consistent, science-based regulatory outcomes.
- Evaluate compliance with FDA regulations, QMSR/QSR requirements, ISO 13485, ISO 14971, IEC 62304, IEC 81001-5-1, AAMI TIR57, AAMI TIR97, FDA cybersecurity guidance, and recognized consensus standards.
- Reviewed Medical Device Reports (MDRs), recalls, and CAPA activities to evaluate device safety and ensure regulatory compliance, contributing to informed decision-making and risk management.
- Provide technical expertise to multidisciplinary review teams, FDA leadership, and external stakeholders
Science Liaison & Reference Standards Scientist
United States Pharmacopeia (USP)
Rockville, MD
04.2016 - 12.2020
- Led analytical characterization and qualification of more than 50 USP Peptide Reference Standards supporting pharmaceutical quality and compendial testing.
- Developed and revised USP Monographs and General Chapters to ensure alignment with global pharmaceutical quality standards.
- Managed Expert Panels and Expert Committee activities to facilitate collaboration among FDA, industry, academia, and international regulatory stakeholders.
- Provided scientific expertise in peptide therapeutics and analytical methods, enhancing understanding of impurities and reference materials in pharmaceutical quality standards.
Principal Investigator
Covance
Chantilly, VA
03.2015 - 04.2016
- Directed regulated analytical and immunoassay development studies under GLP and GCP frameworks.
- Coordinated study execution, data review, laboratory activities, and sponsor communications to ensure compliance and quality.
- Led team of 10+ analysts in daily laboratory operations, enhancing performance and fostering professional development.
- Streamlined laboratory workflows and optimized processes to enhance operational efficiency.
Director, Analytical Development & Quality Control
Texas Children's Hospital – Center for Vaccine Development
Houston, TX
09.2011 - 03.2015
- Directed analytical development, assay qualification, validation, stability studies, and technology transfer activities supporting vaccine clinical development.
- Established and managed quality control laboratory for vaccine development programs, enhancing testing capabilities for hookworm, Chagas disease, and schistosomiasis candidates.
- Developed SOPs and quality systems to ensure laboratory operations met GMP, ICH guidelines, and FDA expectations.
- Authored chemistry, manufacturing, and controls (CMC) documentation for IND submissions, facilitating successful regulatory interactions.
Assistant Professor
Baylor College of Medicine
Houston, TX
09.2011 - 03.2015
- Developed immunological assays that facilitated preclinical evaluation and early clinical vaccine programs, enhancing research outcomes.
- Led translational research in infectious diseases, immunology, and vaccine development, contributing to advancements in public health.
- Collaborated with multidisciplinary academic, clinical, and international research teams to integrate diverse expertise and drive innovative solutions.
Education
B.Sc. - Biological Sciences
Università Degli Studi Di Torino
Turin, Italy07.2000
Ph.D. - Molecular & Structural Biology
University of Leeds
Leeds, UK06.2005
Skills
- Device Regulatory Affairs
- Regulatory review
- In Vitro Diagnostics (IVD) Review
- Software as a Medical Device (SaMD) & Digital Health
- Medical Device Cybersecurity & Vulnerability Management
- AI medical device review
- Clinical Evaluation
- Quality management systems
- Risk management
- Medical Device Standards
- Stakeholder engagement
- Cross-office collaboration
- Mentoring junior reviewers
- Training development
- FDA policy development
- Public stakeholder engagement
ADDITIONAL RESEARCH EXPERIENCE
- Walter Reed Army Institute of Research (WRAIR) — Research Scientist | Silver Spring, MD | 2009–2011
- Developed immunological assays supporting malaria vaccine research; contributed to preclinical studies investigating immune responses to malaria vaccine candidates.
- National Institutes of Health (NIH) — Research Fellow | Bethesda, MD | 2006–2009
- Conducted molecular biology research on DNA translesion synthesis polymerases, investigating mechanisms of DNA damage tolerance and genome stability.
- National Institute for Medical Research (NIMR) — Postdoctoral Research Fellow | London, UK | 2005–2006
- Investigated host–pathogen interactions in tuberculosis immunology; supported translational research and multidisciplinary international collaborations focused on TB vaccine development.
Timeline
Reviewer | Post-Market Quality, Cybersecurity, Diagnostics & Digital Health SME
U.S. Food and Drug Administration (FDA)
01.2021 - Current
Science Liaison & Reference Standards Scientist
United States Pharmacopeia (USP)
04.2016 - 12.2020
Principal Investigator
Covance
03.2015 - 04.2016
Director, Analytical Development & Quality Control
Texas Children's Hospital – Center for Vaccine Development
09.2011 - 03.2015
Assistant Professor
Baylor College of Medicine
09.2011 - 03.2015
B.Sc. - Biological Sciences
Università Degli Studi Di Torino
Ph.D. - Molecular & Structural Biology
University of Leeds