Defense Medical Innovation & Regulatory Advisor

Systems Plus, Inc.; Frederick (MD); On-site; USD 120,000 - 160,000; Full time

Job summary

Systems Plus, Inc. seeks a senior regulatory and clinical development expert to guide DoD medical product programs from discovery through field deployment, collaborating with government leaders, researchers, clinicians, and industry partners.

You will shape regulatory strategy, oversee clinical research activities, and coordinate IMS planning to ensure compliant, timely product development for Warfighters and military healthcare outcomes.

Qualifications

• Medical degree or equivalent in a medical, scientific, or technical field.
• Minimum 10 years in medical product development or clinical trial research.

Responsibilities

• Provide expert guidance on medical technologies, clinical research, regulatory strategy, and product development for DoD programs.
• Attend IPT meetings, site visits, and briefings with government leaders and industry partners.
• Develop Regulatory Affairs strategies and Integrated Master Plans (IMS) for FDA and non-FDA activities.
• Review regulatory submissions (INDs, amendments, annual reports) and safety data.
• Support publication of results in peer-reviewed journals or other media.

Skills

Regulatory strategy

Clinical management

Stakeholder collaboration

FDA/DoD policy analysis

IP/IMS planning

Education

Medical degree or PhD

Job description

Systems Plus, Inc. seeks a senior regulatory and clinical development expert to guide DoD medical product programs from discovery through field deployment, collaborating with government leaders, researchers, clinicians, and industry partners.

You will shape regulatory strategy, oversee clinical research activities, and coordinate IMS planning to ensure compliant, timely product development for Warfighters and military healthcare outcomes.