FDA Inspections Subject Matter Expert (SME)

General Dynamics Information Technology

1d•Hybrid

About The Position

The FDA Inspections SME will provide expert guidance and leadership for GDIT’s SIRCE opportunity, leveraging deep knowledge of FDA regulatory requirements, inspection protocols, and digital transformation initiatives. This role is ideal for a professional who has played a pivotal role in developing and implementing FDA inspection systems such as eNSPECT, and who can bridge regulatory, operational, and IT domains to drive enterprise compliance and innovation.

Requirements

Bachelor’s degree and 12+ years of experience or advanced degree in life sciences, public health, regulatory affairs, or a related field (Master’s or PhD preferred for SME level)
8+ years of experience in FDA regulatory compliance, inspections, or digital transformation within the FDA or regulated industry.
Demonstrated expertise in FDA inspection processes, including hands-on experience with eNSPECT or similar inspection management systems.
Proven ability to translate regulatory requirements into operational and technical solutions.
Experience supporting large-scale federal health IT or regulatory compliance programs is highly desirable.

Nice To Haves

FDA regulatory compliance
Inspection management and digital transformation (e.g., eNSPECT)
Regulatory affairs and policy interpretation
Stakeholder engagement and training
Project management and cross-functional leadership
Technical writing and documentation
Strong communication, stakeholder engagement, and leadership skills.

Responsibilities

Serve as the enterprise lead for all FDA inspection-related subject matter, providing authoritative guidance on regulatory requirements, inspection protocols, and compliance strategies.
Advise on the design, development, and implementation of digital inspection systems, drawing on experience with FDA’s eNSPECT or similar platforms.
Collaborate with cross-functional teams (IT, regulatory, operations, and business development) to ensure SIRCE solutions meet FDA standards and client expectations.
Develop and deliver training, documentation, and best practices for FDA inspections and digital system adoption.
Analyze and interpret FDA regulations, guidance documents, and inspection trends to inform enterprise strategy and client proposals.
Represent GDIT in client meetings, industry forums, and with FDA stakeholders as the recognized inspections SME.
Support proposal development, technical solutioning, and program execution for FDA-related opportunities.

Benefits

Variety of medical plan options, some with Health Savings Accounts
Dental plan options
Vision plan
401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match.
Full flex work weeks where possible
Variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave.
15 days of paid leave per calendar year to be used for vacations, personal business, and illness
10 paid holidays per year
Paid Family Leave program provides a total of up to 160 hours of paid leave in a rolling 12 month period for eligible employees.
Short and long-term disability benefits
Life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available.