[Hiring] Regulatory Affairs Consultant @MDC Associates

Role Description

We are seeking an experienced, independent Regulatory Affairs Consultant to provide ad hoc regulatory support on a contract basis. The ideal candidate brings deep expertise in FDA IVD regulatory pathways—with a particular focus on Antimicrobial Susceptibility Testing (AST) diagnostics—and has hands-on experience with FDA premarket submissions and clinical study design. The successful candidate is comfortable stepping into client engagements with minimal ramp-up time and can serve as a lead correspondent with FDA throughout the submission and review process.

Primary 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

Qualifications

• 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

Preferred Qualifications

• Regulatory Affairs Certification (RAC) from RAPS
• Experience across multiple IVD medical specialties including Microbiology & Infectious Diseases (bloodstream, respiratory, UTI, STI)
• Familiarity with technologies including Real-Time PCR, Molecular Testing, Flow Cytometry, Sequencing, and AI/ML in medical devices
• Experience with software and cybersecurity documentation review for FDA submissions
• Prior experience managing Quality Management Systems at an IVD company
• Publication record or presentations in the IVD or clinical microbiology space

Engagement Details

• Project-based and ad hoc engagements; hours vary by client need
• Remote work with travel to client sites or clinical study locations as required
• Competitive hourly or project-rate compensation commensurate with experience