Regulatory Scientific Reviewer (Biomedical Engineer)

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 1, Band C.

Duties

A Regulatory Scientific Reviewer (Biomedical Engineer) integrates engineering principles - spanning mechanical, electrical, chemical, and materials engineering - with biological and medical sciences to analyze, design, and evaluate medical devices, diagnostic systems, and biomedical technologies. Applies biomechanical, biocompatibility, and systems engineering methods to assess product performance, safety, and fitness for use in clinical and biological environments. Bridges engineering and medicine to provide the rigorous technical expertise required to evaluate devices and technologies intended for use in the diagnosis, treatment, or monitoring of human health conditions. Analyzes complex data and guidelines or criteria for scientific review and approval for a class of products. Identifies risks, gaps, trends, and reviews or coordinates review of important precedent setting scientific issues which establish Agency policy for subsequent reviews of similar products.

Qualifications and evaluation

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.

Education

EDUCATION: chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0800/files/all-professional-engineering-positions-0800.pdf 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. If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements. 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. 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. 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 Applicants using part, or all of their education completed outside of the U.S. to meet the qualification requirements, must have their foreign education evaluated by an accredited organization to ensure that the foreign education is comparable to education received in accredited educational institutions in the U.S. We will only accept the completed foreign credential 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: National Association of Credential Evaluation Services (NACES) 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 : https://sites.ed.gov/international/recognition-of-foreign-qualifications/

How to apply

In accordance with Executive Order 14170, applicants are encouraged to respond to the four short, free-response, essay questions in the questionnaire. Answers to these questions are optional and will not be scored or rated. Your answers will be reviewed by the hiring manager and agency leadership if you are referred for selection consideration. You will be asked to certify that your responses are written in your own words and that you did not use a consultant or artificial intelligence (AI) tool (such as ChatGPT or Copilot). 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. To apply for positions with the Food & Drug Administration, you must log into https://secure.login.gov/ account and be signed in to that account before you click the "Apply Online" button. See the USAJOBS Help Article "How does the application process work?" for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 08/07/2026. We recommend that you start the application process early enough that you can complete and submit your application before this deadline. Please note that you cannot submit documentation or make changes to your application after the deadline, and in most cases, only experience and education obtained by this date will be considered. If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: https://help.usajobs.gov/how-to. Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Contact us at: USAJOBS - Contact us FDA's Applicant Help Desk is not able to support USAJOBS-related issues. The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or you encounter any difficulty with the site, we recommend that you visit the Applicant HELP Site at: https://appsupport-usastaffing.opm.gov/hc/en-us. This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you! You are encouraged to apply online. Applying online will allow you to review and track the status of your application. The FDA will provide reasonable accommodation to applicants with disabilities who are not able to apply online. If you need a reasonable accommodation for any part of the application process, please contact the Applicant Help Desk. Decisions on granting a reasonable accommodation will be made on a case-by-case basis. If after reviewing the USAJOBS and Application Manager help sites, you're not able to find the answer to your question or concern, or if you wish to request a reasonable accommodation, please contact the FDA Applicant Help Desk at 866-807-3742, or e-mail ERIC@fda.hhs.gov The Applicant Help Desk is staffed between the hours of 7am and 6pm Eastern Time, Monday through Friday, except for government holidays. If you contact the Applicant Help Desk, please provide the following Vacancy Identification Number (VIN) 13007101 so that we may assist you faster. Please note: 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. To preview the application questionnaire, click the link below. https://apply.usastaffing.gov/ViewQuestionnaire/13007101

Required documents

Resume: At a minimum, your resume should list the position title, employer name, start and end dates (including month and year), salary (or grade and step), hours worked per week, and a list of duties performed or accomplishments, for EACH position listed. A CV (curriculum vitae) may not contain enough information to meet these resume requirements. USAJobs - What to Include USAJobs - Page Limit Your two (2) page RESUME showing all relevant work experience (paid and unpaid) including: duties performed; full name and address of each employer; start and end dates (month/day/year); work schedule (part-time, full-time, number of hours if intermittent); salary; and any completed education and training (program title, subject area, number of hours completed, and completion date). Transcripts: If the position has an education requirement or you are qualifying based on education, unofficial transcripts or a list of courses must be provided. See the Qualifications and Education Requirements section of this announcement. Additional Documents (if applicable): Cover Letter DD-214/ Statement of Service Disability Letter (Schedule A) Disability Letter (VA) Other supporting documentation not listed above PCS Orders Performance Appraisal Resume Separation Notice (RIF) SF-15 SF-50/ Notification of Personnel Action Transcript Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.

Additional information

The application limit, if applicable, for this advertisement is: No Limit. For more information about announcement closing, see: https://help.usajobs.gov/how-to/job-announcement/closing-types 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. 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 08/07/2026) 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 https://www.opm.gov/frequently-asked-questions/political-appointees-and-career-civil-service-positions-faq/ for more.