Description

You will lead FDA regulatory strategy and execution for Class III PMA IVDs and companion diagnostics, acting as the primary FDA-facing regulatory lead for a Fortune 500 clinical laboratory client. You'll drive complex submissions, lifecycle management, and cross-functional collaboration to align regulatory and business goals.

Requirements

• J.D. and active license to practice law in at least one U.S. jurisdiction
• At least 5 years of in-house experience at a medical device or diagnostics company preferred
• Direct ownership of Class III PMA IVD and/or companion diagnostic submissions
• Recent hands-on experience with Modular PMAs, FDA Q-Subs, PCCPs, SIRs, and lifecycle PMA strategy
• Strong knowledge of FDA regulations and guidance for Class III PMA devices, IVDs, and companion diagnostics

Responsibilities

• 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
• Act as main interface with FDA/CDRH: lead meetings, negotiate positions, draft responses
• Advise on pre- and post-approval requirements (quality systems, risk management, MDRs, labeling)
• Support product classification and premarket strategies for 510(k)-regulated IVDs