Senior Regulatory Affairs SME for DoD Medical Devices

Odyssey Systems Consulting Group, Ltd.; Silver Spring (MD); On-site; USD 110,000 - 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 SME 2 to support the Defense Health Agency at Ft. Detrick, MD. The role provides specialized regulatory guidance for WPAC initiatives and ensures compliance with federal requirements for acute care medical products.

Contingent upon contract award, the expert will collaborate with RA SME 1, develop regulatory strategies, and prepare submissions including INDs, NDAs, PMAs, and 510(k)s for military-relevant solutions.

Qualifications

• US citizen
• Ability to obtain NACI clearance
• Bachelor's degree in a scientific, health, or regulatory field
• At least 8 years of full-time regulatory affairs for medical products
• Experience preparing and reviewing formal FDA submissions

Responsibilities

• Provide expert advice on applying FDA regulations to military-relevant medical solutions.
• Develop and review regulatory strategies, submission planning, and communications with regulatory agencies.
• Prepare and review regulatory submissions including INDs, NDAs, PMAs, and 510(k)s.
• Evaluate regulatory guidelines and interpret impact on developmental programs.
• Conduct gap analyses of processes against current regulatory requirements and mentor team members.

Skills

Regulatory affairs

FDA regulations

NACI clearance

Education

Bachelor's Degree in a scientific, health, or regulatory field

Job description

Odyssey Systems Consulting Group, Ltd. seeks a Regulatory Affairs SME 2 to support the Defense Health Agency at Ft. Detrick, MD. The role provides specialized regulatory guidance for WPAC initiatives and ensures compliance with federal requirements for acute care medical products.

Contingent upon contract award, the expert will collaborate with RA SME 1, develop regulatory strategies, and prepare submissions including INDs, NDAs, PMAs, and 510(k)s for military-relevant solutions.