Regulatory Affairs Subject Matter Expert I

• 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.

Required Qualifications:

• Bachelor's Degree in a scientific, health, or regulatory field.
• At least 8 years of full-time work experience in regulatory affairs for medical products (drugs, biologics, or devices).
• Proven experience preparing and reviewing formal FDA submissions.

Preferred Qualifications:

• Regulatory Affairs Certification (RAC).
• Experience working with DoD-sponsored medical product development initiatives.