FDA Regulatory Attorney – Class III IVD / Companion Diagnostics

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.

Requirements

• Lead FDA regulatory strategy and execution for Class III PMA IVDs and companion diagnostics
• Own strategy, drafting, and management of Modular PMAs, full PMAs, PCCPs, Q-Subs, SIRs, and related submissions
• Act as the main interface with FDA/CDRH: lead meetings, negotiate positions, and draft responses to FDA requests for additional information
• Advise on pre- and post-approval requirements (quality systems, risk management, MDRs, labeling, and other post-market obligations)
• Support product classification and premarket strategies for 510(k)-regulated IVDs, including Q-Sub preparation
• Partner with cross-functional teams (BD, commercial, R&D, quality, manufacturing, legal, regulatory) and external partners to align regulatory and business goals
• Develop and deliver training on FDA regulation of medical devices and IVDs, including approvals/clearances and enforcement topics

Benefits

• Competitive compensation starting at $150,000
• Highly competitive benefits package
• 401K
• Health benefits
• Professional development resources
• Learning and development programs