Regulatory Affairs Subject Matter Expert 2

Position Summary

Odyssey is looking for a Regulatory Affairs SME 2, to support the Defense Health Agency (DHA) at Ft. Detrick, MD.  The Regulatory Affairs Subject Matter Expert 2 acts alongside RA SME 1 to provide specialized regulatory guidance and technical expertise for WPAC initiatives. This expert works to ensure compliance with all federal regulatory requirements and supports the successful development and submission of acute care medical products.

***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. 

***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), and/or 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

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, and holidays.Odyssey Benefits

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. 
***Contingent upon contract award***