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.

Key Responsibilities:

• Lead FDA regulatory strategy and execution for Class III PMA IVDs and companion diagnostics, including lifecycle PMA planning and post‑approval changes.
• 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, M...