FDA Regulatory Attorney – Class III IVD / Companion Diagnostics

<p>We are seeking an experienced FDA Regulatory Attorney with deep, hands-on expertise in Class III PMA in vitro diagnostic (IVD) and companion diagnostic products to work with our client, a Fortune 500 clinical laboratory. This person will serve as the primary FDA-facing regulatory lead, driving strategy and execution for complex submissions and lifecycle management in close partnership with cross-functional and partner teams.</p> <p><strong>Key Responsibilities:</strong></p> <ul> <li>Lead FDA regulatory strategy and execution for Class III PMA IVDs and companion diagnostics, including lifecycle PMA planning and post-approval changes.</li> <li>Own strategy, drafting, and management of Modular PMAs, full PMAs, PCCPs, Q-Subs, SIRs, and related submissions.</li> <li>Act as the main interface with FDA/CDRH: lead meetings, negotiate positions, and draft responses to FDA requests for additional information.</li> <li>Advise on pre- and post-approval requirements (quality systems, risk management, MDRs, labeling, and other post-market obligations).</li> <li>Support product classification and premarket strategies for 510(k)-regulated IVDs, including Q-Sub preparation.</li> <li>Partner with cross-functional teams (BD, commercial, R&D, quality, manufacturing, legal, regulatory) and external partners to align regulatory and business goals.</li> <li>Develop and deliver training on FDA regulation of medical devices and IVDs, including approvals/clearances and enforcement topics.</li> </ul> <p><strong>Qualifications:</strong></p> <ul> <li>J.D. and active license to practice law in at least one U.S. jurisdiction.</li> <li>At least five years of in-house experience at a medical device or diagnostics company is preferred. </li> <li>Direct ownership of <strong>Class III PMA IVD and/or companion diagnostic submissions</strong> (strategy, drafting, and FDA interaction).</li> <li>Recent, hands-on experience with <strong>Modular PMAs, FDA Q-Subs, PCCPs, SIRs, and lifecycle PMA strategy</strong>.</li> <li>Strong knowledge of FDA regulations and guidance for Class III PMA devices, IVDs, and companion diagnostics; familiarity with 510(k) pathways for IVDs preferred.</li> <li>Proven ability to act as the <strong>primary FDA-facing regulatory lead</strong>, work cross-functionally, and communicate clearly with technical and business stakeholders.</li> </ul> <p> </p> <p><strong><span data-contrast="none"><span data-ccp-parastyle="heading 3">Compensation:</span></span></strong><span data-ccp-props="{"134233117":false,"134233118&quot