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).

• 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.

• 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://(Use the "Apply for this Job" box below). 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 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.

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…