Regulatory Counsel (Ombudsman)

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 a Title 21, Pay Table 2, Band D (GS-14 equivalent) . Duties The Ombudsman acts as an independent mediator in disputes related to the regulated industry to resolve issues in a manner that is timely, fair, and impartial. Providing supervision during the ongoing assessment and audits of regulatory matters and quality solutions, such as identifying corrective action plan and/or establishing the appropriate standard operating procedures. Overseeing information-gathering, data collection, and fact-finding throughout multiple organizations with affected persons and groups both internal and external. Overseeing the complaint process related to the scientific, regulatory, and administrative decisions which impacts the Agency’s pending regulatory matters. Collaborating with other key personnel during the regulatory decision-making process with a goal towards improving procedures and increasing public confidence in the safety, effectiveness, and quality of biological related products. Providing supervision during the ongoing assessment and audits of regulatory matters and quality solutions, such as identifying corrective action plan and/or establishing the appropriate standard operating procedures. Leading a variety of substantive activities, such as: receiving and investigating complaints, disagreements, and disputes; providing general information on applicable policies, processes, and procedures. Requirements 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 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. Qualifications In order to qualify for the Regulatory Counsel (Ombudsman) position which falls under the 0301 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/15/2026: Basic Qualifications Requirements: A law degree, specifically a LL.M. or J.D. The degree must be from an accredited program or institution and/or at least two (2) years of comparable regulatory experience focused on interpreting laws, rules, regulations, or policies; or develop or analyze regulations and policies for regulated products. Relevant Years of Experience in Lieu of Education: Seven (7) years of providing analyses and advice on the interpretation of laws, regulations, and policies and guidance applicable for regulated products. Participating or providing leadership in the development, implementation, and evaluation of regulations and policies as they relate to the Agency's programs and activities to ensure the safety, efficacy, and quality of regulated products. 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. 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. 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. 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 U.S. Department of Education website for Foreign Education Evaluation. Additional Information 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: Yes, at the discretion of the supervisor. Financial disclosure statement, OGE-450, required: NO 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 07/15/2026) as an Executive Branch political, ScheduleC, 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 Form50s in your Electronic Official Personnel Folder (eOPF), in Section5 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. Applicants selected for this position will be subject to reasonable suspicion and post-accident drug testing upon hiring. To demonstrate commitment to the HHS goal of a drug-free workplace and to set an example for other Federal employees, employees not in a testing designated position may volunteer for unannounced random testing by notifying their Drug-free Federal Workplace Program Point of Contact upon hiring. 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 (07/15/2026); 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. #J-18808-Ljbffr