Remote Senior Regulatory Analyst (HS/IRB) Part-Time

Remote Genie; Rockville, Northern (MD, KY); Hybrid; USD 140,515,000 - 162,557,000; Part time

Job summary

Ripple Effect is seeking a Senior Regulatory Analyst (HS/IRB) to support OHRP within the U.S. Department of Health and Human Services.

You will review complaints, incident reports, and institutional submissions related to human subjects research, applying the Common Rule (45 CFR 46) and ensuring compliant processes across a diverse portfolio. You will prepare analyses, develop regulatory documentation, and support case management with IRBs, institutions, and investigators while maintaining

Qualifications

• Master’s degree in public health, clinical research, health sciences, biomedical sciences, regulatory affairs, law, public administration, or a related field.
• 8+ years of relevant experience; additional education substitutes for experience.
• Demonstrated experience related to human subjects research protections and regulatory compliance.

Responsibilities

• Be the first point of contact for communications between internal and external parties.
• Review complaints and incident reports for completeness, accuracy, and regulatory significance.
• Provide preliminary assessments and draft correspondence for leadership and case teams.
• Track case status, milestones, and required follow-ups to support transparency and audit readiness.
• Apply knowledge of the Common Rule (45 CFR 46) and regulatory requirements to evaluations.

Skills

IRB experience

Regulatory compliance

Common Rule

Regulatory reporting

Regulatory submissions

Documentation

Education

Master’s degree

Public health

Regulatory affairs

Tools

Microsoft Planner

Microsoft Project

Asana

Smartsheet

Job description

Ripple Effect is seeking a Senior Regulatory Analyst (HS/IRB) to support OHRP within the U.S. Department of Health and Human Services.

You will review complaints, incident reports, and institutional submissions related to human subjects research, applying the Common Rule (45 CFR 46) and ensuring compliant processes across a diverse portfolio. You will prepare analyses, develop regulatory documentation, and support case management with IRBs, institutions, and investigators while maintaining