FDA Fellowship - Strategic Modernization of Regulatory Taxonomy: Energy Based Surgical Devices

Oak Ridge Institute for Science and Education; Silver Spring (MD); Sur place; USD 30 466 - 36 493; Plein temps

Avantages offerts par ce poste

Monthly stipend commensurate with educational level and experience

Résumé du poste

The Oak Ridge Institute for Science and Education is seeking candidates for a year-long research opportunity at the FDA in Silver Spring, Maryland. This role involves optimizing Total Product Life Cycle oversight by designing classification schemes for medical devices, which includes evaluating technologies and assessing benefit-risk profiles.

Successful candidates will hold or be pursuing a Master’s or Doctoral degree in various engineering fields. Full-time participation is required, and a monthly stipend will be provided.

Qualifications

• Currently pursuing or holding a master’s or doctoral degree in engineering or medical device-related fields.
• Understanding of medical devices and technologies.
• Ability to conduct comprehensive evaluations and design classification schemes.

Responsabilités

• Support optimization of Total Product Life Cycle oversight.
• Evaluate existing devices and their technologies.
• Design classification schemes for medical device regulation.
• Create benefit/risk-based product codes.

Connaissances

Research and analytical skills

Understanding of regulatory science

Strategic thinking

Technical writing

Project management

Formation

Master’s Degree or Doctoral Degree in relevant field

Description du poste

Organization

The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), is located in Silver Spring, Maryland. CDRH’s mission is to protect and promote public health by ensuring safe, effective, and high‑quality medical devices and safe radiation‑emitting products. The center advances regulatory science, provides industry with transparent pathways, and enhances post‑market surveillance.

Reference Code

FDA-CDRH-2026-0023

Research Project

To optimize Total Product Life Cycle (TPLC) oversight, you will develop a strategic structure for categorizing medical device types. Your work will involve evaluating current devices, assessing technologies, evolving clinical indications, and benefit‑risk profiles. Using this analysis, you will design a hierarchical classification scheme and create benefit/risk‑based product codes to replace legacy categories, thereby improving pre‑market review efficiency and post‑market surveillance.

Responsibilities & Learning Objectives

• Support optimization of TPLC oversight through strategic categorization.
• Conduct comprehensive evaluations of existing devices, including underlying technologies, clinical indications, and benefit‑risk profiles.
• Design hierarchical classification schemes to enhance regulatory organization.
• Create benefit/risk‑based product codes by restructuring legacy device categories into specific groupings.
• Contribute to initiatives that improve technology trend tracking, streamline pre‑market reviews, and strengthen post‑market surveillance.

Mentor

The mentor for this opportunity is Cal Rabang ([e-mail]).

Appointment Details

Start Date: October 12, 2026 (flexible).

Length: One year, renewable upon recommendation and contingent on funding availability.

Level of Participation

Full time.

Participant Stipend

Monthly stipend commensurate with educational level and experience.

Citizenship Requirements

Available to U.S. citizens, Lawful Permanent Residents, and foreign nationals. Non‑U.S. citizens must meet the immigration status guidelines provided by ORAU.

Education

Participants must read and sign FDA Education and Training Agreement within 30 days of start date. The agreement covers non‑employee status, prohibition of inherently governmental functions, intellectual property rights, ownership of research materials, and confidentiality obligations.

Qualifications

Candidate should be currently pursuing or holding a master’s or doctoral degree in a relevant field.

Eligibility Requirements

• Degree: Master’s Degree or Doctoral Degree.
• Discipline:
  • 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 of U.S. citizenship or residency for 36 months in the past 60 months.
• Read the FDA Ethics Requirements.