Regulatory Affairs Subject Matter Expert 2

About the role

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. 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.

Responsibilities

• 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.

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.

Benefits

• 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

Schedule

Travel: 10%; Work arrangement: Onsite.