FDA Regulatory Attorney – Class III IVD / Companion Diagnostics
Axiom is seeking an experienced FDA Regulatory Attorney specializing in Class III PMA in vitro diagnostic (IVD) and companion diagnostic products to join their team remotely. This role involves serving 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.
The key responsibilities include leading FDA regulatory strategy and execution for Class III PMA IVDs and companion diagnostics, managing Modular PMAs, full PMAs, PCCPs, Q-Subs, SIRs, and related submissions, acting as the main interface with FDA/CDRH, advising on pre- and post-approval requirements, supporting product classification and premarket strategies for 510(k)-regulated IVDs, and developing and delivering training on FDA regulation of medical devices and IVDs.
Candidates should possess a J.D. and an active license to practice law in at least one U.S. jurisdiction, with at least 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, recent hands-on experience with Modular PMAs, FDA Q-Subs, PCCPs, SIRs, and lifecycle PMA strategy, and strong knowledge of FDA regulations and guidance for Class III PMA devices, IVDs, and companion diagnostics are essential.
The estimated total compensation for this full-time role ranges from $1,045,000 to $3,250,000 per year, based on various factors including experience, skills, certifications, location, and business needs. Employees may also be eligible for additional benefits such as health, dental, and vision insurance; paid holidays and PTO; flexible work arrangements; and professional development opportunities and tools.
Axiom is a global leader in high-caliber, on-demand legal talent, serving over 1,500 legal departments worldwide. The company values agility, collaboration, and excellence, offering a dynamic and multi-faceted career environment. Axiom's commitment to diversity and inclusion is core to its values, ensuring equal employment opportunities without discrimination or harassment.