FDA Regulatory Attorney – Class III IVD / Companion Diagnostics

Overview

An experienced FDA Regulatory Attorney is sought to serve as the primary FDA-facing regulatory lead for a Fortune 500 clinical laboratory client. This role requires deep, hands-on expertise in Class III PMA in vitro diagnostic (IVD) and companion diagnostic products. The attorney will drive strategy and execution for complex submissions and lifecycle management, collaborating closely with cross-functional and partner teams.

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 such as 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 including business development, commercial, R&D, quality, manufacturing, legal, and regulatory to align regulatory and business goals.
• Develop and deliver training on FDA regulation of medical devices and IVDs, covering approvals, clearances, and enforcement topics.

Requirements

• Juris Doctor (J.D.) degree and active license to practice law in at least one U.S. jurisdiction.
• Minimum of five 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, including strategy, drafting, and FDA interaction.
• 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.
• Familiarity with 510(k) pathways for IVDs is preferred.
• Proven ability to act as the primary FDA-facing regulatory lead, work cross-functionally, and communicate clearly with technical and business stakeholders.

Compensation & Benefits

• Estimated total compensation for full-time attorney roles ranges from $104,500 to $325,000 per year.
• Compensation decisions are based on factors including experience, skills, certifications, location, and business needs.
• Additional benefits may include health, dental, and vision insurance; paid holidays and paid time off; flexible work arrangements; and professional development opportunities.

Location

This position supports a client based in the United States. Specific location details and work arrangements will be discussed during the hiring process.