Develop, compile, review, and submit FDA premarket submissions including 510(k), De Novo, and Pre-Market Approval (PMA) applications
Prepare and submit FDA Q-Submissions including Pre-Submissions, Breakthrough Device Designation Requests, and Submission Issue Requests
Identify appropriate regulatory pathways for new IVDs and conduct predicate device comparisons
Design analytical and clinical studies in accordance with FDA guidance documents, predicate device comparisons, and regulatory communications—with specific experience in AST diagnostic studies
Act as lead correspondent with FDA throughout the submission and review process
Create Clinical Study Protocols, Statistical Analysis Plans, Manuals of Procedures, and other clinical study documentation
Prepare Clinical Study Reports with results analysis suitable for FDA submission
Assist clients in identifying and contracting with Clinical Trial Sites and/or Reference Laboratories
Assist with Institutional Review Board (IRB) submissions
Review software and cybersecurity documentation for FDA premarket submissions
Provide regulatory guidance and strategic input to IVD medical device manufacturers throughout product development

Advanced degree in a scientific discipline (e.g., Microbiology, Biochemistry, Chemical Biology, or related field)
Minimum 8–10 years of regulatory affairs experience in IVD medical devices or life sciences
Demonstrated hands-on experience with FDA IVD regulatory pathways: 510(k), De Novo, Pre-Submissions, Breakthrough Device Designation
Direct experience with Antimicrobial Susceptibility Testing (AST) diagnostics regulatory submissions or clinical study design
Proficiency in analytical and clinical study design for IVD products
Familiarity with FDA Quality System Regulations (21 CFR Part 820) and ISO 13485
Strong written and verbal communication skills; ability to draft clear, well-organized submission documents
Ability to work independently across multiple client engagements with minimal oversight

Regulatory Affairs Consultant – Contract, Ad Hoc Support

Key skills