Regulatory Affairs Support (Warfighter Expeditionary Medicine and Treatment)

Odyssey Systems Consulting Group, Ltd.; Frederick (MD); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life insurance

TRICARE supplement

Short-term disability

Long-term disability

401(k) match

Flexible spending accounts

Health savings accounts

Employee assistance program

Learning and development benefit

Paid time off

Holidays

Job summary

Odyssey Systems Consulting Group, Ltd. seeks a Regulatory Affairs Support SME to assist the Defense Health Agency at Ft. Detrick, MD.

The role focuses on FDA regulatory requirements for the WEMT division, guiding product development, submissions, and lifecycle management for drugs, biologics, and medical devices used in expeditionary medicine. Responsibilities include shaping regulatory strategies, preparing submissions (INDs/NDAs/PMAs/510(k)s), and mentoring teammates on best practices in a DoD

Qualifications

• US citizenship required.
• Ability to obtain NACI clearance.
• Bachelor's degree in a scientific, health, or regulatory field.
• 8+ years of regulatory affairs experience for medical products.

Responsibilities

• Provide expert advice on FDA regulations for military-relevant medical solutions.
• Develop and review regulatory strategies, submission planning, dossier preparation, and communication with regulatory agencies.
• Prepare and review regulatory submissions including INDs, NDAs, PMAs, and 510(k)s.
• Evaluate and interpret regulatory guidelines and policies to assess their impact on developmental programs.
• Conduct gap analyses of existing processes against current regulatory requirements and provide mentorship to team members on best practices.
• Assist in the development of an Integrated Master Plan (IMP).

Skills

Regulatory guidance

FDA regulations

Regulatory submissions

Education

Bachelor's degree in scientific/health/regulatory field

Tools

INDs/NDAs/PMAs/510(k)s

Job description

Position Summary

Odyssey is looking for a Regulatory Affairs Support (Warfighter Expeditionary Medicine and Treatment) to support the Defense Health Agency (DHA) located at Ft. Detrick, MD. This Regulatory Affairs Support SME provides specialized guidance and in-depth expertise on FDA regulatory requirements for the WEMT division. This technical resource ensures successful product development, submission, and lifecycle management for drugs, biologics, and medical devices utilized in expeditionary medicine.

***Contingent upon contract award***

Responsibilities

Duties include, but are not limited to:

• Provide expert advice and guidance on the application of FDA regulations to the development of military-relevant medical solutions.
• Develop and review regulatory strategies, submission planning, dossier preparation, and communication with regulatory agencies.
• Prepare and review regulatory submissions including INDs, NDAs, PMAs, and 510(k)s.
• Evaluate and interpret regulatory guidelines and policies to assess their impact on developmental programs.
• Conduct gap analyses of existing processes against current regulatory requirements and provide mentorship to team members on best practices.
• Assist in the development of an Integrated Master Plan (IMP).

***Contingent upon contract award***

Qualifications

Minimum Required Qualifications:

• Citizenship: Must be a US citizen.
• Clearance : Ability to Obtain NACI.
• Education: Bachelor's Degree in a scientific, health, or regulatory field.
• Years of Experience: At least 8 years of full-time work experience in regulatory affairs for medical products (drugs, biologics, or devices).

Other Experience:

• Proven experience preparing and reviewing formal FDA submissions.

Preferred Qualifications

Certifications: Regulatory Affairs Certification (RAC). Experience working with DoD-sponsored medical product development initiatives. Experience with DHA/USAMMDA preferred.

Additional Information

Location: Defense Health Agency (DHA), 1430 Veterans Drive, Fort Detrick, MD 21702

Travel: 10%

Remote, Onsite, or Hybrid: Onsite

#LI-JC1

***Contingent upon contract award***

Company Overview

Odyssey is a world-class technical, engineering, and integration company serving the warfighting ecosystem with airborne integration, ISR, C2, and warfighter readiness capabilities. Odyssey meets the military's operational needs by integrating layered defense systems from equipment, technology, and services to data, information, and business operations. We streamline defense acquisition and sustainment, engineering the technical battlefield with domain-specific proficiency to ensure lethality. Odyssey is dedicated to excellent contract execution, peak organizational performance, and fostering a workplace built on employee care.

Odyssey is proud to live out our core values of commitment, ambition, and respect in our work and communities through OdysseyCares, a philanthropic group focused on giving back through direct donations, an employer match program, and volunteering events.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

We are an equal opportunity employer and provide an inclusive environment for all individuals.

Please Note:

Final compensation for this position will be determined by various factors such as the Federal Government contract labor categories and contract wage rates, relevant work experience, specific skills and competencies, geographic location, education, and certifications.

This position is filled through continuous recruitment and will remain open until a sufficient pool of applications has been received.

Hired applicants may be eligible for benefits, including but not limited to:

• medical
• dental
• vision
• life insurance
• Tricare supplement
• short-term disability
• long-term disability
• 401(k) match
• flexible spending accounts
• health savings accounts
• employee assistance program
• learning and development benefit
• paid time off
• holidays

Odyssey Benefits