FDA Fellowship - Strategic Modernization of Regulatory Taxonomy: Energy Based

Organization

U.S. Food and Drug Administration (FDA)

Reference Code

FDA-CDRH-2026-0023

How To Apply

To submit your application, scroll to the bottom of this opportunity and click APPLY.

A Complete Application Consists Of

• An application
• Transcripts – Click here for detailed information about acceptable transcripts
• A current resume/CV, including academic history, employment history, relevant experiences, and publication list
• One educational or professional recommendation

All documents must be in English or include an official English translation.

If you have questions, send an email to ORISE.FDA.CDRH@orau.org. Please include the reference code for this opportunity in your email.

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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: A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), located in Silver Spring, Maryland.

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: To optimize Total Product Life Cycle (TPLC) oversight, strategic structure in categorization needs to be developed and implemented for these medical device types. You will conduct a comprehensive evaluation of current devices, assessing their underlying technologies, evolving clinical indications, and distinct benefit-risk profiles. Utilizing this analysis, you will architect a novel hierarchical classification scheme and develop a targeted strategy to parse the legacy categories into entirely new, specific, and benefit/risk-based product codes. This initiative will directly enhance the center's ability to track technological trends, streamline premarket reviews, and strengthen post-market surveillance.

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

• Learn to support optimization of Total Product Life Cycle (TPLC) oversight for medical devices through strategic categorization efforts.
• Gain experience conducting comprehensive evaluations of existing devices, including their underlying technologies, evolving clinical indications, and distinct benefit-risk profiles.
• Develop skills in designing hierarchical classification schemes to improve regulatory organization and clarity.
• Learn to create benefit/risk-based product codes by systematically restructuring legacy device categories into more specific groupings.
• Contribute to initiatives that enhance the Center’s ability to track technological trends, streamline premarket review processes, and strengthen post-market surveillance activities.

Mentor: The mentors for this opportunity are Yan Fu (Yan.Fu@fda.hhs.gov) and Colin Chen (Kejing.Chen@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentors.

Anticipated Appointment Start Date: October 12, 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 be currently pursuing or have received a master's or doctoral degree in the one of the relevant fields.

Point of Contact

Ashley

Eligibility Requirements">29 )

• Degree: Master's Degree or Doctoral Degree.
• Discipline(s):
• Engineering (
• Aerospace and Aeronautical
• Agricultural Engineering
• Architectural Engineering
• Bioengineering and Biomedical Engineering
• Biological/Biosystems Engineering
• Chemical Engineering
• Civil Engineering
• Communications Engineering
• Computer and Systems Engineering
• Electrical and Electronic Engineering (including Cybersecurity)
• Energy
• Engineering (General)
• Engineering Physics
• Engineering Sciences
• Environmental Engineering
• Geophysical Engineering
• Industrial Engineering
• Materials Science Engineering
• Mechanical Engineering
• Mechatronics, Robotics, and Automation Engineering
• Metallurgical Engineering
• Mining and Minerals Engineering
• Naval Architecture and Marine Engineering
• Nuclear Engineering
• Ocean Engineering
• Petroleum Engineering
• Polymer Engineering
• Radiation Protection
• Systems Engineering (including Human Systems)

Affirmation

I am a U.S. citizen, or 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.)

and

I have read the FDA Ethics Requirements.