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Posted: March 27, 2026 (0 days ago)

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Digital Health Specialist

Food and Drug Administration

Department of Health and Human Services

Fresh

Location

Salary

$143,913 - $226,144

per year

Type

Closes

April 3, 2026More FDA jobs →

Job Description

Summary

This job involves leading the creation and review of rules and guidelines for digital health technologies, such as AI in medicine and software used as medical devices, at the FDA.

The role supports innovation in areas like cybersecurity for devices and real-world evidence from clinical studies.

It's a good fit for someone with a technical background in science or engineering who has hands-on experience in health tech policy or regulation.

Key Requirements

  • Bachelor's degree or higher in science, technology, engineering, mathematics, computer science, statistics, or software engineering from an accredited institution
  • Comparable experience in digital health areas such as policy, technology support, training, medical device cybersecurity, AI/machine learning, regulatory science, review coordination, advanced manufacturing, real-world evidence, advanced clinical studies, regulatory innovation, or strategic partnerships
  • For bachelor's degree holders: At least 5 years of relevant experience
  • For master's degree holders: At least 4 years of relevant experience
  • For doctorate, J.D., MD, DO, DDS, DPM, or DVM holders: At least 2 years of relevant experience
  • Alternative: 7 years of relevant experience without a qualifying degree
  • Submission of relevant transcripts to verify education

Full Job Description

This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624.

The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.

This position is being recruited based on the Title 21 Pay Table 2, Band D.

In order to qualify for the Digital Health Specialist position which falls under the 0301 occupational Series, you must meet the following requirements by 11:59 pm EST on 04/03/2026: Basic Qualification Requirements: Have a bachelor's degree or higher in a science, technology, engineering, mathematics, computer science, statistics, or software engineering.

The degree must be from an accredited program or institution.

OR Have comparable experience in digital health policy, digital health technology support, digital health training, medical device cybersecurity, artificial intelligence/machine learning, regulatory science advancement, regulatory review support and coordination, advanced manufacturing, real world evidence and advanced clinical studies, regulatory innovation, or digital health strategic partnership.

IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS.

I have a bachelor's degree and have 5 years of comparable experience in digital health policy, digital health technology support, digital health training, medical device cybersecurity, artificial intelligence/machine learning, regulatory science advancement, regulatory review support and coordination, advanced manufacturing, real world evidence and advanced clinical studies, regulatory innovation, or digital health strategic partnership.

OR I have a master's degree and have 4 years of comparable experience in digital health policy, digital health technology support, digital health training, medical device cybersecurity, artificial intelligence/machine learning, regulatory science advancement, regulatory review support and coordination, advanced manufacturing, real world evidence and advanced clinical studies, regulatory innovation, or digital health strategic partnership.

OR I have a Doctorate and/or J.D.

degree and have 2 years of comparable experience in digital health policy, digital health technology support, digital health training, medical device cybersecurity, artificial intelligence/machine learning, regulatory science advancement, regulatory review support and coordination, advanced manufacturing, real world evidence and advanced clinical studies, regulatory innovation, or digital health strategic partnership.

OR I have a MD, DO, DDS, DPM, or DVM degree and have 2 years of comparable experience in digital health policy, digital health technology support, digital health training, medical device cybersecurity, artificial intelligence/machine learning, regulatory science advancement, regulatory review support and coordination, advanced manufacturing, real world evidence and advanced clinical studies, regulatory innovation, or digital health strategic partnership.

OR I have 7 years of comparable experience in digital health policy, digital health technology support, digital health training, medical device cybersecurity, artificial intelligence/machine learning, regulatory science advancement, regulatory review support and coordination, advanced manufacturing, real world evidence and advanced clinical studies, regulatory innovation, or digital health strategic partnership.

NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications. Major Duties:

Leads development, review, and implementation of policies, regulations, and guidance for digital health technologies (including AI/ML and software as a medical device).

Serves as a technical and scientific advisor on digital health to internal leadership and external stakeholders.

Provides regulatory and scientific expertise to support evaluation of digital health products and medical devices.

Advances collaboration with government agencies, industry, academia, and international partners on digital health initiatives.

Analyzes emerging technologies, trends, and business models to inform regulatory strategy and policy development.

Develops and delivers training, presentations, and guidance materials on digital health topics. Represents FDA/CDRH in national forums, advisory panels, and stakeholder engagements.

Identifies opportunities and risks related to digital health innovation, including impacts on public health and regulatory processes.

Supports strategic planning and program direction for digital health initiatives across the Agency.

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Posted on USAJOBS: 3/27/2026 | Added to FreshGovJobs: 3/28/2026

Source: USAJOBS | ID: FDA-CDRH-26-T21-12920162-DZ