FDA Office and Location: A research opportunity is available within the Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA), located at Silver Springs, Maryland.

Oak Ridge Institute for Science and Education (ORISE) Research Participation Programs at the U.S. Food and Drug Administration are educational training programs designed to provide students and recent graduates, opportunities to participate in project- specific research and developmental at the Center for Devices and Radiological Health (CDRH). The mission of CDRH is to protect and promote public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH provides consumers, patients, caregivers, and providers with understandable and accessible science-based information about products. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

Research Project: As an ORISE participant, you will join and learn from a community of scientists and researchers engaged in a soft tissue filler (dermal filler) device research project. You will participate in creating a database of technical parameters vs. safety and effectiveness data for fillers to allow correlation of clinical evidence and device characteristics, and streamline comparison across different products.

The Division of Plastic and Reconstructive surgery oversees the total product life cycle of dermal filler medical devices, which are injected materials used to add volume or reduce the appearance of wrinkles for aesthetic purposes, generally in the face.

Learning Objectives: Under the guidance of a mentor, you will learn:

Scientific Collaboration & Regulatory Oversight: Collaborate with a multidisciplinary review team to understand the Total Product Life Cycle (TPLC) and FDA regulation of dermal filler devices. Database Development: Create and manage a database that maps the parameters of dermal fillers to their safety and effectiveness data. Literature Review & Landscape Analysis: Conduct comprehensive literature reviews to build a foundational understanding of the current scientific, clinical, and regulatory landscape of dermal filler devices. Mentor: The mentor for this opportunity is Jodie Giordano (Jodie.Giordano@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date: 2026/2027. Start date is flexible and will depend on a variety of factors.

Appointment Length: The appointment will initially be for one year but may be renewed upon recommendation of FDA and is contingent on the availability of funds.

Level of Participation: The appointment is full time.

Participant Stipend: The participant will receive a monthly stipend commensurate with educational level and experience.

Citizenship Requirements: This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non- U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.

This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment- related benefits.

Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.