FDA Artificial Intelligence and Machine Learning Fellowship

Oak Ridge Institute for Science and Education; White Oak (MD); On-site; USD 36,000 - 58,000; Full time

Job summary

U.S. Food and Drug Administration (FDA) offers a research fellowship through ORISE at the White Oak, Maryland site.

The Artificial Intelligence Regulatory Science Program conducts regulatory science research to ensure safe AI/ML-enabled medical devices, addressing data challenges, bias, and evolving algorithms. The fellowship starts Spring 2026, runs for one year with potential renewal, and provides a monthly stipend commensurate with education and experience.

Qualifications

• Master's or Doctoral degree in a relevant field.
• Eligible disciplines include Computer Science, Data Science, AI, Engineering, and related fields.
• Background in regulatory science or AI-enabled medical devices is a plus.

Responsibilities

• Gain comprehensive understanding of regulatory science approaches for AI/ML-enabled medical devices.
• Develop methods for training algorithms with limited data and for bias analysis and minimization.
• Evaluate AI devices that can adapt post-deployment and plan for post-market monitoring.

Skills

Regulatory science

AI/ML

Data challenges

Communication

Education

Master's or Doctoral Degree in a relevant field

Job description

Organization

U.S. Food and Drug Administration (FDA)

Reference Code

FDA-CDRH-2026-0011

Application Deadline

9/30/2027 3:00:00 PM Eastern Time Zone

Description

Applications will be reviewed on a rolling-basis.

FDA Office and Location

Up to 14 research fellowships are available with the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) located in White Oak, 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

The Artificial Intelligence Regulatory Science Program conducts regulatory science research ensuring safe and effective AI/ML-enabled medical devices across rapidly expanding healthcare applications including image processing, disease detection, diagnosis, and therapeutic monitoring. The program addresses critical regulatory challenges posed by AI devices that can continuously learn and adapt, including the unique nature of clinical medical data with low disease prevalence and difficulty obtaining ground truth data. Major regulatory science gaps include lack of methods for AI algorithm training with limited data, bias analysis and minimization, performance metrics and uncertainty quantification, evaluation of continuously learning algorithms, and post-market monitoring.

Learning Objectives

• Gain comprehensive understanding of regulatory science approaches for AI/ML-enabled medical devices, including performance assessment methodologies and uncertainty quantification methods.
• Acquire specialized skills in addressing critical data challenges in medical AI, including methods for training algorithms with limited datasets, synthetic data evaluation, and approaches to minimize algorithmic bias.
• Develop expertise in evaluating AI devices that can adapt and learn post-deployment, including understanding evolving algorithms and creating methodologies to assess algorithm performance changes over time.

Mentor

The mentor(s) for this opportunity are Ravi Samala ([e-mail]) and Aldo Badano ([e-mail]). If you have questions about the nature of the research, please contact the mentor(s).

Anticipated Appointment Start Date

Spring 2026. 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.

FDA Ethics Requirements

If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists.

Education

FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following:

• Non-employee nature of the ORISE appointment;
• Prohibition on ORISE Fellows performing inherently governmental functions;
• Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
• The fact that research materials and laboratory notebooks are the property of the FDA;
• ORISE fellow’s obligation to protect and not to further disclose or use non-public information.

Qualifications

The qualified candidate should have received or be currently pursuing a master's or doctoral degree in the one of the relevant fields.

Point of Contact

Richard

Eligibility Requirements

• Degree: Master's Degree or Doctoral Degree received within the last 60 months or anticipated to be received by 5/31/2026 12:00:00 AM.
• Discipline(s):
  • Computer, Information, and Data Sciences (Artificial Intelligence (including Robotics, Computer Vision, Human Language Processing, and Machine Learning))
  • Computer Architecture and Grids
  • Computer Science - Languages and Systems
  • Computer Science - Theoretical Foundations
  • Computer Science (general)
  • Computer Systems Analysis
  • Computer Systems Design (including Signal Processing)
  • Data Science
  • Databases, Information Retrieval, and Web Search
  • Graphics and Visualization
  • Human Computer Interaction
  • Information Science and Technology
  • Information Security and Assurance
  • Networks and Communications
  • Operating Systems and Middleware
  • Scientific Computing and Informatics
  • Software Engineering
• Engineering (29 )
  • Life Health and Medical Sciences (3 )
    • Mathematics and Statistics (11 )
      • Physics (16 )

Affirmation

I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)

I have read the FDA Ethics Requirements.