Regulatory Affairs Consultant – Contract / Ad Hoc Support

MDC Associates is seeking an experienced Regulatory Affairs Consultant to provide ad hoc regulatory support on a contract basis, with a focus on FDA IVD regulatory pathways, particularly in Antimicrobial Susceptibility Testing (AST) diagnostics.

Requirements

• Develop, compile, review, and submit FDA premarket submissions
• Prepare and submit FDA Q-Submissions
• Identify appropriate regulatory pathways for new IVDs
• Design analytical and clinical studies
• Act as lead correspondent with FDA throughout the submission and review process
• Create Clinical Study Protocols and Reports
• Assist clients in identifying and contracting with Clinical Trial Sites and/or Reference Laboratories
• Review software and cybersecurity documentation for FDA premarket submissions

Benefits

• Competitive hourly or project-rate compensation