Regulatory Affairs Consultant

Regulatory Affairs Consultant – Contract / Ad Hoc Support About MDC Associates MDC Associates (MDC) is a full-service CRO dedicated to supporting innovators and entrepreneurs bringing In Vitro Diagnostics (IVD) and Medical Devices to market that impact the lives of millions of patients around the world. Initially founded to provide Regulatory and Quality guidance, we identified a need for highly skilled Clinical Affairs, Clinical Operations, and Data Management services and built our CRO to best ensure our client's success. We're proud of our 35+ year track record providing guidance and resources that have helped to deliver next-generation advances in microbiology, clinical chemistry, infectious disease and companion diagnostics (CDx) that contribute to a healthier world. Role Overview 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.

Key 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

Required 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 submission
• 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