Regulatory Affairs Consultant – Contract, Ad Hoc Support
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Job Description
Regulatory Affairs Consultant providing ad hoc FDA regulatory support for IVD medical devices. Seeking expertise in FDA IVD regulatory pathways, especially Antimicrobial Susceptibility Testing diagnostics.
Responsibilities:
- 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
Requirements:
- 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
Benefits:
- Competitive hourly or project-rate compensation commensurate with experience
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