Regulatory Systems Manager

Defense Health Agency; Frederick (MD); On-site; USD 90,000 - 120,000; Full time

Job summary

The Defense Health Agency (DHA) MRDC unit is seeking a Regulatory Systems Manager to oversee FDA‑compliant IT systems and document control. The role focuses on ensuring regulatory alignment across systems, document management, and cross‑functional collaboration within a highly regulated environment.

Ideal candidates will have deep experience with eCTD drafting, policy implementation, training, enforcement, and leading a diverse team of technical experts in regulated settings.

Qualifications

• Experience with FDA‑compliant regulated IT systems (e.g., EDMS, Lorenz, Argus, EDC).
• Experience drafting and formatting documents per eCTD standards.
• Experience developing policies and procedures for regulated systems, quality management, trials.
• Experience leading diverse technical teams in a regulated environment.

Skills

FDA-regulated IT systems

eCTD standards drafting/editing

Policy/procedure development

Team leadership in regulated systems

Education

Bachelor's or graduate degree in health sciences or related field

Job description

About the Position:

MRDC is now part of the Defense Health Agency (DHA) Research & Development (R&D). We are the medical materiel developer, with responsibility for medical research, development and acquisition. Our expertise in these critical areas helps establish and maintain the capabilities the military needs to remain ready and lethal on the battlefield.

Who May Apply:

US Citizens DHA Research & Development (R&D) is participating in an alternative personnel system known as the Personnel Demonstration Project (PDP).

The DB-03 payband is equivalent to the GS-13 step 1 to GS-14 step 10 level. In keeping with the Demonstration pay fixing policies, employees earning a salary that falls within this payband equivalent, may not receive an immediate pay increase (promotion) if appointed to this position. Future pay increases within the payband will be accomplished through the pay for performance management system. This is a Direct Hire Authority (DHA) solicitation utilizing the DHA for Certain Personnel of the DoD Workforce to recruit and appoint qualified candidates to positions in the competitive service. In order to qualify, you must meet the education and experience requirements described below. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community; student; social). You will receive credit for all qualifying experience, including volunteer experience. Your resume must clearly describe your relevant experience; if qualifying based on education, your transcripts will be required as part of your application. Additional information about transcripts is in this document.

Basic Requirement for Regulatory Systems Manager:

Degree: Bachelor's or graduate (or higher level) degree with 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 accredited by an accrediting body recognized by the U.S.Department of Education at the time the degree was obtained. You MUST submit copies of your transcripts supporting your education.

Specialized Experience:

• 1. Experience working with or managing FDA compliant regulated IT systems, such as: EDMS, Lorenz,Argus, EDC, etc.
• 2. Experience drafting, editing, and formatting documents in compliance with electronic common technical document (eCTD) standards.
• 3. Experience developing and implementing new policies and procedures involving regulated systems,quality management systems, and/or clinical trials, including training, enforcement, and tracking performance metrics.
• 4. Experience leading a diverse team of technical experts in a regulated systems field. This definition of specialized experience is typical of work performed at the next lower grade/level position in the federal service (DB-02 / GS-12).