Regulatory Affairs Consultant

Regulatory Affairs Consultant – Contract / Ad Hoc SupportAbout MDC AssociatesMDC 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 OverviewWe 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 ResponsibilitiesDevelop, compile, review, and submit FDA premarket submissions including 510(k), De Novo, and Pre-Market Approval (PMA) applicationsPrepare and submit FDA Q-Submissions including Pre-Submissions, Breakthrough Device Designation Requests, and Submission Issue RequestsIdentify appropriate regulatory pathways for new IVDs and conduct predicate device comparisonsDesign analytical and clinical studies in accordance with FDA guidance documents, predicate device comparisons, and regulatory communications—with specific experience in AST diagnostic studiesAct as lead correspondent with FDA throughout the submission and review processCreate Clinical Study Protocols, Statistical Analysis Plans, Manuals of Procedures, and other clinical study documentationPrepare Clinical Study Reports with results analysis suitable for FDA submissionAssist clients in identifying and contracting with Clinical Trial Sites and/or Reference LaboratoriesAssist with Institutional Review Board (IRB) submissionsReview software and cybersecurity documentation for FDA premarket submissionsProvide regulatory guidance and strategic input to IVD medical device manufacturers throughout product developmentRequired QualificationsAdvanced 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 sciencesDemonstrated hands-on experience with FDA IVD regulatory pathways: 510(k), De Novo, Pre-Submissions, Breakthrough Device DesignationDirect experience with Antimicrobial Susceptibility Testing (AST) diagnostics regulatory submissions or clinical study designProficiency in analytical and clinical study design for IVD productsFamiliarity with FDA Quality System Regulations (21 CFR Part 820) and ISO 13485Strong written and verbal communication skills; ability to draft clear, well-organized submission documentsAbility to work independently across multiple client engagements with minimal oversightPreferred QualificationsRegulatory Affairs Certification (RAC) from RAPSExperience 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 devicesExperience with software and cybersecurity documentation review for FDA submissionPrior experience managing Quality Management Systems at an IVD companyPublication record or presentations in the IVD or clinical microbiology spaceEngagement DetailsProject-based and ad hoc engagements; hours vary by client needRemote work with travel to client sites or clinical study locations as requiredCompetitive hourly or project-rate compensation commensurate with experience