FDA Regulatory Attorney – Class III IVD / Companion Diagnostics - Remote

Overview

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.

In Short

• Lead FDA regulatory strategy and execution for Class III PMA IVDs and companion diagnostics.
• Own strategy, drafting, and management of regulatory submissions.
• Act as the main interface with FDA/CDRH.
• Advise on pre- and post-approval requirements.
• Support product classification and premarket strategies.
• Partner with cross-functional teams to align regulatory and business goals.
• Develop and deliver training on FDA regulation of medical devices and IVDs.

Requirements

• J.D. and active license to practice law in at least one U.S. jurisdiction.
• At least five years of in-house experience at a medical device or diagnostics company.
• Direct ownership of Class III PMA IVD and/or companion diagnostic submissions.
• Hands-on experience with Modular PMAs and related submissions.
• Strong knowledge of FDA regulations for Class III PMA devices.
• Proven ability to act as the primary FDA-facing regulatory lead.

Benefits

• Competitive compensation starting at $150,000.
• Comprehensive health benefits.
• 401K plan.
• Access to professional development resources.
• Learning and development programs.