VersaTech is seeking a Technical Business Analyst to support the FDA Program, bridging FDA stakeholders and the development team as the program implements AI solutions into its technology stack and adopts AI-enabled tools across the software development lifecycle. The analyst owns requirements elicitation, process analysis, user story development, and acceptance criteria for application enhancements and AI-enabled capabilities, and serves as the translation layer between mission users and engineers.
This is a hands-on technical role. The successful candidate can read application code, work in the data, follow an integration end to end, and hold a credible design conversation with engineers, rather than passing requirements across a wall and waiting for a demonstration.
The FDA Program supports application development, sustainment, and modernization. The program is implementing AI solutions into its technology stack, integrating AI capabilities into the applications, data services, and workflows FDA users rely on. In parallel, it is introducing AI-assisted capabilities into its delivery practice, including code generation and review assistants, automated test case generation, requirements analysis tooling, and document summarization for regulatory and user artifacts.
This role calls for a working business analyst who understands how AI solutions and AI tooling change requirements definition, test coverage, acceptance, and the documentation trail a federal customer expects, and who can keep that change defensible to a government stakeholder.
Salary: $100,000 - $125,000 depending on experience.
Key Responsibilities
Requirements and Analysis
- Lead elicitation, documentation, and validation of functional and non functional requirements with stakeholders across multiple FDA offices, end users, and technical leads, translating complex regulatory and operational needs into implementable requirements
- Distill complex regulatory business processes into user stories, thorough acceptance criteria, and process flows that a development team can build from without rework
- Perform as-is and to-be process analysis, gap analysis, and impact assessment for proposed application changes; document concepts of operations, regulatory business rules, reviewer roles, and decision points, and identify opportunities to simplify or automate review workflows
- Assess dependencies across applications and technologies, including AI services, workflow, enterprise search, and reporting
- Define data requirements, including field mappings, validation rules, reporting and search needs, and role-based access requirements
- Maintain requirements baselines and end-to-end traceability from stakeholder need through requirement, build, test, and acceptance, linking requirements to acceptance criteria, test cases, and UAT results
- Assess operational and functional baselines, identify process inefficiencies, and recommend prioritized improvements aligned with stakeholder and project needs
AI Solutions, AI-Assisted Review, and AI-Enabled Development Support
- Identify and define high-value AI-assisted review and workflow automation use cases with FDA subject matter experts and developers; develop and refine prompts, define evaluation criteria and human review steps, and measure outcomes
- Define business, functional, and data requirements for AI solutions being integrated into the program's technology stack, including model inputs and outputs, integration points, performance expectations, and human oversight
- Identify where AI assistance adds measurable value in the delivery lifecycle, including requirements drafting, test case generation, code review support, and documentation
- Define acceptance criteria and validation steps for AI-assisted outputs so that human review and sign-off remain documented
- Draft and refine prompts, templates, and reusable patterns for team use, and capture what works in program-level guidance
- Track and report on AI tooling adoption, cycle time effects, and defect trends for program leadership
- Flag data handling, privacy, and records implications of AI tool usage to the Program Manager and the Government customer
Agile Delivery
- Support backlog grooming, sprint planning, sprint review, and retrospectives
- Define and manage backlog and release needs in partnership with the product owner, with requirements focused on usability, user experience, and user adoption
- Plan and coordinate user acceptance testing with FDA users and QA, including test scenario development, UAT scheduling, defect triage and clarification, and documentation of stakeholder validation
Stakeholder Engagement and Documentation
- Serve as the day-to-day functional point of contact for assigned FDA stakeholders
- Help define the direction and strategy for stakeholder engagement, ensuring project needs are addressed across FDA offices
- Facilitate requirements workshops, demonstrations, and working sessions, on site when needed
- Produce and maintain program documentation, including requirements specifications, process models, standard operating procedures, user guides, training material, and release notes
- Support user adoption, and track and adjudicate post-release feedback with business owners
- Support contract deliverables and status reporting as directed by the Program Manager
Required Qualifications
- Four-year bachelor's degree or higher in information systems, computer science, engineering, business administration, life sciences, or a related field
- Seven or more years of experience on information technology projects, including seven or more years of business and functional requirements analysis covering user stories, acceptance criteria, process modeling, and stakeholder validation
- Five or more years of experience translating business needs into requirements for enterprise applications, workflows, and system integrations
- Experience leading requirements, managing stakeholder decisions, and coordinating requirements across parallel initiatives
- Ability to work independently with minimal supervision in a fast-paced, dynamic environment, and to collaborate across IT and business functions
- Technical fluency sufficient to reason about REST APIs, data flows, data models, and integration points, to write requirements an engineer can build from, and to question a design or an estimate on its merits
- Working knowledge of SQL, including the ability to write queries, profile a dataset, and validate data independently rather than waiting on a developer
- Ability to produce technical artifacts, including data flow diagrams, system context diagrams, interface and API specifications, and data dictionaries
- Demonstrated experience delivering under Agile, Waterfall, and hybrid methodologies, with the judgment to work within whichever approach a given task order, release, or customer stakeholder requires
- Working experience on an Agile delivery team, including backlog grooming, sprint planning, sprint review, and retrospectives, as well as experience producing the structured requirements and phase documentation a Waterfall effort depends on
- Proficiency writing user stories, acceptance criteria, process flows, and requirements traceability artifacts
- Proficiency with requirements and collaboration tools, including Jira, Visio, SharePoint, and Excel
- Experience coordinating user acceptance testing and defect triage, including the ability to reproduce a defect and isolate it before it reaches a developer
- Excellent written, verbal, and interpersonal communication, with the ability to brief both technical teams and non technical program stakeholders
- Demonstrated success delivering quality work products and taking ownership of tasks
- Ability to obtain and maintain a federal Public Trust clearance. Candidates must be able to pass the required background investigation
- Ability to travel to the FDA campus in College Park, Maryland on a periodic basis
- United States citizenship or other status that satisfies the Government's suitability requirements for this contract
Preferred Qualifications
- Currently supporting the Food and Drug Administration
- Prior business analysis experience on a federal government contract
- Experience on FDA IT projects, or supporting HHS or another regulated public health or life sciences environment
- Experience with AI-assisted business solutions, LLM use case definition and evaluation, or Appian (or equivalent low-code) workflow implementation
- Hands-on experience applying AI tools within a software development context, such as AI coding assistants, AI-assisted test generation, requirements analysis tooling, or LLM-based document analysis
- Active Public Trust or higher clearance, or a prior favorable federal background investigation
- A background in software development, quality assurance, systems engineering, or database administration before moving into business analysis
- Hands-on software development or cloud experience (AWS or Azure), including the ability to read application code and familiarity with version control, CI/CD pipelines, and enterprise application architecture
- Experience applying ITIL service management practices in an application operations and maintenance environment, including incident, problem, change, and release management
- Experience supporting DevSecOps delivery, including CI/CD pipelines, automated testing, and security controls built into the pipeline rather than applied after the fact
- Experience working under a CMMI appraised process, or supporting CMMI appraisal preparation and evidence collection
- Familiarity with other recognized delivery and quality frameworks, such as SAFe, ISO 9001, or Lean Six Sigma
- Familiarity with federal software delivery expectations, including Section 508 accessibility, ATO and security documentation support, and records retention
- Hands-on experience with specific AI development tooling, for example GitHub Copilot, Amazon Q Developer, Claude, or Azure OpenAI, including evaluation of output quality
- Familiarity with AI governance frameworks relevant to federal use, such as the NIST AI Risk Management Framework
- Experience with Confluence, Azure DevOps, or an equivalent backlog and documentation toolset
- Working ability to script in Python or an equivalent language for data profiling, validation, or lightweight automation
- Certification such as CBAP, PMI-PBA, Certified Scrum Product Owner, ITIL Foundation, or an equivalent Agile credential
Location, Travel and Clearance
This role is primarily remote, with up to one day on site. Candidates must live within commuting distance of the Washington DC metropolitan area. The analyst must be able to reach the FDA campus in College Park, Maryland for periodic on-site working sessions, requirements workshops, demonstrations, and stakeholder meetings. On-site frequency is scheduled in advance with the customer.
A federal Public Trust clearance is required for this position. VersaTech will sponsor the investigation for a selected candidate who does not hold a current Public Trust, and the start date may depend on favorable adjudication or interim approval. Candidates holding a current Public Trust or a recent favorable federal background investigation will be given preference because they can begin work sooner.
Find out who we are: https://www.versatechinc.com/
VersaTech offers an excellent benefits package that includes medical, dental, and vision benefits, 401k employer-matching retirement contributions after 90 days, generous paid time off (3 weeks PTO plus 11 holidays), and ample growth opportunities.
VersaTech, Inc. is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity/Affirmative Action Employer, making decision without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class.