Regulatory Specialist 252281

We are looking to add a fully remote Regulatory Specialist with CRO/Sponsor experience in a PRN capacity to lend support. This will be a W2 contract and support is expected to be needed for up to 12 months. Hours can very week to week but will be flexible. Candidates must currently live in the state of Florida.

Qualifications

• Bachelor’s degree required; advanced degree (MS, MPH, PhD, JD) preferred in life sciences, regulatory affairs, or related field.
• 3–7 years of experience in regulatory affairs, clinical research, or a related role.
• Direct experience with IRB submissions and clinical study startup.
• Familiarity with FDA regulations and guidance for LDTs and Software as a Medical Device (SaMD), particularly AI/ML-based systems.
• Strong understanding of GCP, human subjects research regulations, and informed consent requirements.
• Excellent writing, communication, and organizational skills.
• Ability to work under tight timelines and manage multiple priorities.
• Experience with adaptive or self-learning AI/ML systems in a clinical or regulatory context.
• Prior involvement in protocol development and amendments for diagnostic studies.
• Experience working in a fast-paced, cross-functional environment.

Position Summary

The Regulatory Research Specialist will provide expert regulatory guidance and operational support for clinical studies involving diagnostic Laboratory Developed Tests (LDTs), with a focus on emerging FDA frameworks for self-learning AI/ML-enabled software. This role is responsible for ensuring regulatory compliance, supporting study design and execution, and leading interactions with Institutional Review Boards (IRBs), including protocol amendments and informed consent updates.