Regulatory Affairs Consultant – Contract / Ad Hoc Support

MDC Associates•Beverly, MA

1d•Hybrid

About The Position

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.

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

Nice To Haves

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

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