Summary

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.

Duties

Help

• Develops and implements cybersecurity legislation, policies, guidance documents, and white papers to establish and advance cybersecurity requirements for medical devices.
• Ensures requirements address key areas including risk management, secure architectures, security controls, secure update mechanisms, software bill of materials (SBOM), coordinated vulnerability disclosure (CVD) and other controls as identified.
• Supports the development and implementation of a cybersecurity strategic plan and roadmap.
• Incorporates lessons learned and continuously re-evaluates cybersecurity policy to ensure the Center's frameworks evolve in response to emerging cybersecurity challenges.
• Reviews, analyzes, and assesses proposed initiatives, agreements, and legislation from other organizations and governments to determine the feasibility of FDA participation and identify potential conflicts with FDA's regulatory mandates.
• Provides expert recommendations on the impact of external proposals on FDA's cybersecurity program.
• Provides routine cybersecurity incident and vulnerability response
• Provides expert consultation and recommendations of cybersecurity implementation to premarket submissions as needed
• Active in industry discussions and working groups to support cybersecurity of medical devices
• Other duties as assigned

Requirements

Help

Conditions of employment

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• The candidate selected for this position will serve under a career or career-conditional appointment within the competitive service.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• Males born after December 31, 1959, must be registered with the Selective Service. Please go to http://www.sss.gov for more information.
• Financial Disclosure may be required.
• Ethics Clearance may be required.
• Probationary periods are required for new employees appointed to competitive service positions for the first time; or reinstated employees who return after a break in service of 30-days or more and who have not completed a probationary period.

Qualifications

In order to qualify for the Regulatory Cybersecurity Specialist position which falls under the 0301 occupational Series, you must meet the following requirements by 11:59 pm EST on 09/01/2026:

Basic Qualification Requirements:

Education: 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

Experience: Comparable work 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

Minimum Qualifications: Comparable experience is experience that equipped the applicant with the knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled. The relevant experience must demonstrate one year of full-time work experience, or the equivalent if part-time (for example, an employee working 20 hours per week for a 12-month period should be credited with 6 months of experience). Experience may have been obtained in either the federal service or its equivalent with state or local government, the private sector, or nongovernmental organizations.

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

Have a bachelor's degree and 5 years of comparable experience demonstrating understanding in cybersecurity vulnerability analysis, operational technology, information technology, information management, or a related field.

OR

Have a master's degree and 4 years of comparable experience demonstrating understanding in cybersecurity vulnerability analysis, operational technology, information technology, information management, or a related field.

OR

Have a Doctorate and/or J.D. degree and 2 years of comparable experience demonstrating understanding in cybersecurity vulnerability analysis, operational technology, information technology, information management, or a related field.

OR

Have a MD/DO/DDS/DPM/DVM degree and 2 years of comparable experience demonstrating understanding in cybersecurity vulnerability analysis, operational technology, information technology, information management, or a related field.

OR

Have 7 years of comparable experience demonstrating understanding in cybersecurity vulnerability analysis, operational technology, information technology, information management, or a related field.

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

Education

Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.

TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.

If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements.

Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.

Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation.

To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery.

Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded.

Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below:

1. National Association of Credential Evaluation Services (NACES)
2. Association of International Credentials Evaluators (AICE)

Credential evaluations are not free, and applicants are responsible for the cost of the selected service.

For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.

Additional information

The application limit, if applicable, for this advertisement is: N/A

Additional Conditions of Employment:

• Pre-employment physical required: No
• Drug testing required: No
• License required: No
• Mobility agreement required: No
• Immunization required: No
• Bargaining Unit: No
• Telework eligible position: Telework is at the discretion of the supervisor.

• Financial disclosure statement, OGE-450, required: Please be advised that this position may be subject to FDA's prohibited financial interest regulation and may require the incumbent of this position to divest of certain financial interests. Applicants are advised to seek additional information on this requirement from the hiring official before accepting this position.

Additional Information:

• Additional selections may be made for similar positions within the commuting area(s) of the locations listed through this vacancy announcement.
• Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
• If you are serving, or have served in the last 5 years (from 09/01/2026) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. See Political Appointee FAQ - OPM for more.

Active-duty U.S. Public Health Service Commissioned Corps Officers are encouraged to apply. If selected, officers may either (1) remain on active duty assigned to the designated billet for PHS assignment, or (2) separate or retire from the Commissioned Corps before entering a Title 21 civilian appointment.

All requirements must be met by the closing date of this announcement (09/01/2026); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.

Expand Hide additional information

Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution.

Benefits

Help