Regulatory Systems Manager: A Critical Role in Medical R&D
In the high-stakes world of military medical research, the intersection of technology and regulation is where safety meets innovation. The Defense Health Agency (DHA) Research and Development Activity is seeking a motivated Regulatory Systems Manager to guide the operational integrity of their medical materiel development programs. If you possess a background in health sciences and a mastery of FDA-regulated IT environments, this role offers a chance to make a tangible impact on the readiness and care of our armed forces.
Job Responsibilities
The Regulatory Systems Manager is responsible for ensuring that all IT systems and programs within the Office of Regulated Activities remain in full compliance with DHA and FDA standards. Key duties include:
- Managing user accounts and system training for internal regulatory platforms.
- Authoring and updating Standard Operating Procedures (SOPs) to ensure audit-readiness.
- Overseeing the lifecycle of eCTD-compliant documentation.
- Conducting metric-based assessments to track system performance and risk mitigation.
- Spearheading the implementation of a comprehensive Quality Management System (QMS).
Requirements
This position requires a unique blend of technical experience and regulatory knowledge. Candidates must:
- Hold a bachelor's or graduate degree in a field related to medical or health sciences.
- Possess one year of specialized experience at the GS-12 equivalent level.
- Demonstrate proficiency with FDA-regulated tools such as EDMS, Lorenz, or EDC.
- Have experience leading technical teams and managing complex quality reviews.
Salary Overview
The compensation for this role is competitive, reflecting the expertise required for this high-level position.
| Pay Component | Details |
|---|---|
| Salary Range | $121,785 – $187,093 (Annual) |
| Pay System | Personnel Demonstration Project (PDP) |
| Payband | DB-03 (Equivalent to GS-13/14) |
Benefits
Working for the DHA offers more than just a paycheck. Employees gain access to a robust suite of federal benefits, including comprehensive health coverage, life insurance, retirement planning, and generous leave policies. Furthermore, the role allows for professional development within a dynamic, research-focused environment.
Application Tips
Competition for this role is significant. To maximize your chances, adhere strictly to the two-page resume limit. Clearly articulate how your past projects directly align with the specialized experience requirements (FDA compliance, eCTD, and team leadership). Ensure your resume includes all required metrics (start/end dates, employer info) to prevent being disqualified for an incomplete application.
This role is an ideal career move for a regulatory professional who thrives on detail, accuracy, and technical leadership. If you are ready to apply your skills to support military health and readiness, this vacancy is a perfect match. Prepare your documents, double-check your resume, and submit your application to the Defense Health Agency today.
Why This Regulatory Systems Manager Job Matters
Advance your career in medical research oversight at the Defense Health Agency, where your technical expertise ensures the safety and efficacy of mission-critical healthcare solutions.
Regulatory Systems Manager Job Overview
The Defense Health Agency (DHA) is seeking a skilled Regulatory Systems Manager to join the Research and Development Activity at Fort Detrick, Maryland. This role is pivotal in overseeing FDA-regulated IT systems and quality management frameworks that support the development of life-saving medical materiel for our service members. As a key member of the Office of Regulated Activities, you will bridge the gap between complex regulatory requirements and high-level technical execution.
Requirements for Regulatory Systems Manager
- U.S. Citizenship is required.
- Completion of a Bachelor's or graduate degree in a field related to medical, health, or allied sciences.
- At least one year of specialized experience equivalent to the GS-12 level.
- Documented experience managing FDA-compliant regulated IT systems (e.g., EDMS, Lorenz, Argus, EDC).
- Proven track record in drafting and formatting eCTD-compliant documentation.
- Experience developing and implementing quality management policies and performance metrics.
- Demonstrated ability to lead a diverse team of technical experts.
- Must be able to successfully complete a three-year probationary period.
Preferred Qualifications for Regulatory Systems Manager
- Advanced technical knowledge of FDA regulatory frameworks.
- Strong proficiency in quality management system (QMS) development.
- Experience in cross-functional team leadership within a government or research environment.
- Ability to analyze, mitigate, and report on complex IT systems risks.
Federal Benefits & Perks
- ✓Competitive federal salary with locality pay.
- ✓Comprehensive health and life insurance options.
- ✓Participation in the federal retirement system.
- ✓Paid federal holidays and leave accrual.
- ✓Career growth within the Defense Health Agency.
- ✓Access to the Personnel Demonstration Project (PDP) pay-for-performance system.
💡 How to Apply Regulatory Systems Manager Job & Insider Tips
Application Steps for Regulatory Systems Manager Job
- Log in or create an account on USAJOBS.
- Prepare a resume that is strictly limited to two pages or less.
- Collect all relevant academic transcripts to support your educational requirements.
- Complete the online application questionnaire through the provided portal.
- Upload your resume, transcripts, and any optional supporting documents (e.g., cover letter, performance appraisal).
- Submit your complete application package before the closing date of September 11, 2026.
- Monitor your status via the USAJOBS dashboard.
💡 General Tips
- Keep your resume to two pages; documents exceeding this limit will be removed from consideration.
- Ensure your resume explicitly maps your work history to the 'Specialized Experience' requirements listed.
- Avoid acronyms; use plain language to describe your accomplishments.
- Verify that your resume includes employer names, job titles, start/end dates, and average hours worked per week.
- Submit early to allow sufficient time for uploaded files to clear the mandatory virus scan process.
Frequently Asked Questions
What is the pay system for this position?
This position operates under the Personnel Demonstration Project (PDP) pay-for-performance system, with a payband (DB-03) equivalent to GS-13/14.
Is remote work available?
No, this position is not listed as telework or remote-eligible.
Can I substitute education for the required experience?
No, this position requires candidates to meet the qualification requirements through experience alone.
What is the residency requirement for this job?
*A: This position is located at Fort Detrick, Maryland, and is not a remote role.*
How are promotions handled?
*A: As part of the Demonstration Project, pay increases are determined by the pay-for-performance management system rather than automatic step increases.*
Job from Defense Health Agency
The Defense Health Agency is a vital component of the Department of Defense, serving as a unified combat support agency. The Research and Development Activity (MRDC) plays a key role in identifying, developing, and acquiring medical technologies that protect and treat service members on the front lines. By joining this team at Fort Detrick, you become part of a mission-driven organization dedicated to delivering healthcare excellence to over 9.5 million uniformed beneficiaries.