Regulatory IT Systems Lead (FDA‑Compliant)

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

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.