Bachelor's Degree in a scientific, health, or regulatory field
Minimum 8 years of regulatory affairs experience for medical products
Experience preparing and reviewing FDA submissions
Responsibilities
Provide expert regulatory advice on FDA regulations for military medical solutions
Develop and review regulatory strategies and submission plans
Prepare and review submissions including INDs, NDAs, PMAs, and 510(k)s
Interpret regulatory guidelines to assess their impact on projects
Conduct gap analyses against regulatory requirements and mentor team members
Benefits
Working in a pivotal role supporting military healthcare initiatives
Opportunity to influence the development of acute care medical products
Engagement with federal regulatory processes and agencies
Professional growth opportunities in a specialized field
Collaborative environment with a focus on mentorship and guidance
Full Job Description
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***
About Odyssey Systems
Odyssey Systems is an information technology company based in Rockville, Maryland. It was founded in 1997 and provides a range of IT services to government agencies and private sector clients. Odyssey Systems specializes in software development, data analytics, and cybersecurity. The company has a team of over 500 employees and has worked with clients such as the Department of Defense, the Department of Homeland Security, and the National Institutes of Health. Odyssey Systems is committed to providing innovative solutions to its clients and helping them achieve their goals.
