Office Director, Office of Health Technology IV
What you'd do
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 4, Band G.
Major duties
Directs the Office of Health Technology 4 (OHT4) which oversees the regulation of surgical and infection control medical devices. Establishes scientific policy, regulatory guidance, and technical direction for surgical and infection control medical devices across the total product lifecycle. Leads development and execution of Office programs, strategic initiatives, and long- and short-term organizational goals aligned with Center priorities. Provides leadership, supervision, and performance oversight for OHT4 managers and staff while fostering scientific excellence and operational effectiveness. Serves as a nationally recognized expert in total product lifecycle (TPLC) regulation of surgical and infection control medical devices. Directs end-to-end medical device review programs from premarket evaluation through postmarket surveillance and compliance activities. Oversees premarket review programs, including 510(k), PMA, HDE, De Novo, IDE, and 513(g) submissions. Directs OHT4 compliance programs involving inspections, recalls, labeling, enforcement actions, regulatory audits, and misconduct investigations. Oversees OHT4 postmarket surveillance programs, including Medical Device Reports, safety signal assessments, 522 studies, and post-approval studies. Analyzes compliance and performance data to inform regulatory decisions and support Office and Center initiatives. Reviews and approves complex medical device regulatory decisions to ensure compliance with applicable laws, regulations, and scientific standards. Serves as a principle advisor to OPEQ leadership on scientific, regulatory, operational, and strategic matters regarding the regulation of surgical and infection control medical devices.
What you need to qualify
In order to qualify for the Office Director, Office of Health Technology IV position which falls under the 0601 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/21/2026: The candidate must meet the following qualifications for this Title 21 position: Scientific, Technical, and/or Professional Fields Qualified and Outstanding Candidates a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the technical qualifications defined below as a baseline for comparing experience levels and other candidate attributes for relevant positions b, Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both. Minimum Qualifications: Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U. S. Department of Education at the time the degree was obtained. In addition to meeting the basic requirements outlined above, applicants must also meet one of the following minimum years of experience requirements: Bachelor's degree and minimum 8 years of experience Master's degree and minimum 7 years of experience Doctorate, JD, MD, DDS, DPM, or DVM and minimum 5 years of experience This position is designated as an SES Equivalent position and is covered under the FDA Title 21 Executive Performance Management System and identified as a public filing position for ethics purposes. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications. Supervisory Responsibilities: The incumbent provides occupational specific technical and administrative direction 25 percent or more of the time to three or more subordinate employees performing the work and functions of the organization. Obtains resources and identifies strategic objectives for the organization. Defines jobs, selects employees, and assigns work; defines technical work requirements and milestones; evaluates the organization and employee accomplishments by accepting or rejecting work products; and presents and defends organization and employees work to senior management and other offices. Recommends employee promotions and recognition; approves leave; implements performance modifications and takes corrective actions as appropriate. Provides employees with resources and information that ensure a safe and healthy work environment. 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. 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 http://www.sss.gov for more information. 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. All applicants tentatively selected for this position will be required to submit to urinalysis to screen for illegal drug use prior to appointment and be subject to random, reasonable suspicion, and post-accident drug testing upon hiring. Appointment to the position will be contingent upon a negative applicant drug test result. 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. 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. Ethics preclearance/OGE-278, required: Please be advised that this position is 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. For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics. Financial disclosure statement, required: This position requires financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment. Applicants must meet all qualification requirements by the closing date of this announcement.
Before you apply
Federal applications are different: your resume should be 3–5 pages and mirror the language of this announcement. Read our federal resume guide first — it's the #1 reason qualified people get screened out.
Don't miss the next one.
Get an email the moment a similar federal job opens — postings can close in as little as 5 days.