Regulatory Cybersecurity Specialist
Job Location:
Silver Spring, MD - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job 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.
- 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 Centers 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 FDAs regulatory mandates.
- Provides expert recommendations on the impact of external proposals on FDAs 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
- 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.
- FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises you must take affirmative steps to resolve the matter.
- Males born after December 31 1959 must be registered with the Selective Service. Please go to for more information.
- Financial Disclosure may be required.
- Ethics Clearance may be required.
- Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired you may be subject to additional investigations at a later time.
- Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration non-selection or appropriate legal action.
- 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.
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 bachelors 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 bachelors 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 masters 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.
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 applicants educational program earned abroad and the standard obtained; (4) The status of the awarding foreign schools recognition and legitimacy in its home countrys 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:
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.
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 FDAs 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 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 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.
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.
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.
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
