Digital Health Specialist - Generative Artificial Intelligence

Summary:
The position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), CDRH/DHCoE/DDHT and being filled under FDA’s Title 21 hiring authority. This hiring authority was passed by Congress in December 2016, to improve FDA’s ability to recruit and retain scientific, technical, and professional experts in certain occupational series that “support the development, review, and regulation of medical products.” The FY23 Omnibus Appropriations Bill expanded the hiring authority to include cross-cutting positions and individuals that support the development, review, and regulation of food and cosmetics in addition to medical products. Both statutes amended the FD&C Act 21 USC. This hiring authority is a streamlined hiring authority, outlined in 21 USC 379d-3a, as amended by the 21st Century Cures Act of 2016, § 3072 and the Consolidated Appropriations Act of 2023, § 3624.

This job is open to: Open to the Public

You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. This is a 21st Century Cures Act authority announcement. Traditional federal rules regarding rating, ranking, and veterans' preference do not apply.
Duties
The Digital Health Specialist bridges generative AI expertise, with the broader regulatory and strategic landscape of health care technology innovation. The Digital Health Specialist requires collaboration with regulatory experts, policymakers, and health care professionals to ensure that AI models used in medical devices meet the highest standards of safety, performance, and compliance with federal regulations. The Digital Health Specialist leads and contributes to complex and innovative projects as part of an agile team of experts within a fast-paced and technically demanding ecosystem.

The Digital Health Specialist supports public health through the development, review, and
implementation of regulations, policies, procedures and guidances related to software and digital health. Serves as a technical and scientific consultant and advisor to the Division Director, Digital Health Technology Assessment and provides expertise and consultation to engineers, scientists, industry representatives, consultants, and clinical investigators on scientific, statistical, and regulatory aspects of digital health products to include machine learning and artificial intelligence, including generative artificial intelligence. The Digital Health Specialist uses various methods, processes, and techniques to support the development and delivery of public health or health-related programs.

As an expert in formal scientific principles and experience in Health IT, the incumbent provides information, advice, and consultation to government entities, federal agencies, private industry, and/or universities on unique and complex scientific or regulatory issues. Serves as an official representative and collaborates on a national level with scientists and government officials on a wide range of regulatory issues. Initiates, develops, and disseminates guidance, policies, procedures, and training materials for digital health technologies to include software as a medical device, machine learning and artificial intelligence including generative artificial intelligence. Exercises discretion, analytical skill, judgment and personal accountability and responsibility for developing research programs.

Provides scientific expertise as well as specialized analytical expertise on a wide variety of regulatory issues and matters. Establishes and maintains liaisons with medical device companies, professional organizations, industry associations/groups, patient advocacy groups, academia, and other federal and foreign agencies with mutual interest in digital health as it pertains to medical devices.

Analyzes and evaluates the implementation of new software and digital health policies that impact CDRH’s mission and initiates analyses as it relates to advances in digital health technologies. (e.g., systems, software development, etc.). Presents, explains, and justifies recommended project/program management activities to senior CDRH and Digital Health Center of Excellence management. The incumbent provides medical device regulatory support for digital health issues.

Analyzes current and emerging business models related to digital health using input from investment community, industry, healthcare providers, patients, staff, and other stakeholders. Proactively identifies technology trends and evolving science that may influence digital health technologies, medical device development, evaluation, and regulatory policy. Develops and provides strategic direction related to software and digital health with various CDRH scientific and professional staff, investment community, industry, device manufacturers, healthcare providers, patients, staff, and other stakeholders, specifically in medical device community.

Prepares and/or delivers legislative testimony on consumer and regulatory, and policy analysis issues regarding digital health. Makes presentations at medical and scientific review panels, advisory committees, formal professional meetings at the national level, and before large consumer groups. Leads the development and presentation of national and local training programs within the digital health arena.

Reviews, analyzes, and improves digital health policy proposals and related regulatory deliverables including how technical changes affect medical device product safety and public health. Identifies opportunities and barriers for the development of innovative medical devices incorporating digital health technologies and improving the processes both internal and external related to software and digital health that may affect regulatory/policy changes greatly. Coordinates with other subject matter experts on the development and dissemination of regulatory health policy. Communicates strategies related to software and digital health to include machine learning and artificial intelligence, including generative artificial intelligence with internal and external stakeholders.

Identifies opportunities for innovation and assess the healthcare marketplace for obstacles and technical hurdles to the business success of digital health technologies. Represents the Center within and outside FDA on projects pertaining to digital health program requirements. Identifies opportunities and risks for modifying CDRH’s digital health approach to premarket review and post market surveillance of medical devices to promote timely, efficient scientific assessment and review of innovative products.

Makes significant technical contributions that advance the state-of-the-art technology used in Cyber-Physical Systems. Determines when major developments should be reconsidered, or major alterations should be made due to program changes. Partners with other government and industry experts to develop new concepts and approaches for Digital Health programs in the center.

Presents CDRH’s policies to national organizations, government agencies, state and local governments, industry, academia, consumer organizations, Congress, and/or the scientific community.

How to Apply
Submit resume or curriculum vitae, cover letter (please be sure to clearly define the number of years using month and year training completed, in addition to describing duties performed during that time period), SF50 (if applicable), a copy of your unofficial transcripts (if applicable), by 11/20/2024 to CDRHRecruitment@fda.hhs.gov. Compile all applicant documents into one combined document (i.e., Adobe PDF). Candidate resumes may be shared with hiring official within the CDRH with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. Please include the following Job Reference ID in the subject line of your email submission: CDRH/DHCoE/DDHTA Digital Health Specialist-Generative Artificial Intelligence

PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply to this announcement. Officers must follow the instructions for how to apply and include their most recent orders in addition to the required documents. If selected, candidates will be referred to (CC) personnel and not as candidates for a Cures appointment.

All requirements must be met by the closing date of this announcement 11/20/2024; only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.
How you will be Evaluated:
You will be evaluated for this job based on how well you meet the qualifications above.
This is a Title 21 announcement. Traditional rating and ranking of applications, and veterans' preference does not apply to this vacancy. You will be evaluated against the basic qualifications and if found qualified, you will be referred to the Hiring Manager for consideration.

If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or results of an oral presentation or work-related test.
Failure to comply with any of the additional assessment requirements will result in removal from further consideration.

Please follow all instructions carefully. Errors or omissions may affect your eligibility.