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 focuses on Class III PMA in vitro diagnostic (IVD) and companion diagnostic products, driving regulatory strategy and execution for complex submissions and lifecycle management in collaboration 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.
• Manage strategy, drafting, and submission of Modular PMAs, full PMAs, PCCPs, Q-Subs, SIRs, and related regulatory filings.
• Serve as the main interface with FDA/CDRH: lead meetings, negotiate positions, and draft responses to FDA requests for additional information.
• Provide advice on pre- and post-approval requirements such as quality systems, risk management, medical device reporting (MDRs), labeling, and other post-market obligations.
• Support product classification and premarket strategies for 510(k)-regulated IVDs, including preparation of Q-Subs.
• Collaborate with cross-functional teams including business development, commercial, R&D, quality, manufacturing, legal, and regulatory, as well as external partners to align regulatory and business objectives.
• 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 and hands-on experience with Class III PMA IVD and/or companion diagnostic submissions, including strategy, drafting, and FDA interaction.
• Recent 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 effectively with both 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 consider factors such as 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.

The organization is an equal opportunity employer committed to diversity and inclusion. Reasonable accommodations are available upon request for candidates with disabilities during the recruitment process. Employment may be contingent upon successful background checks, proof of identity, and legal authorization to work in the U.S. Qualified applicants with arrest and conviction records will be considered in accordance with applicable fair chance laws.