FDA Regulatory Attorney – Class III IVD, Companion Diagnostics

🕒 January 12

🇺🇸 United States – Remote

💵 $150k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧑‍💼 Attorney

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Axiom

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2000

☁️ SaaS

🤝 B2B

Legal • SaaS • B2B

Axiom is a company that provides legal services and law-related technology, simplifying the process of managing legal accounts for users. Their focus on accessibility and user-friendly processes highlights their commitment to modernizing the legal experience.

📋 Description

• 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, 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 (BD, commercial, R&D, quality, manufacturing, legal, regulatory) and external partners to align regulatory and business goals. • Develop and deliver training on FDA regulation of medical devices and IVDs, including approvals/clearances and enforcement topics.

🎯 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 is preferred. • Direct ownership of Class III PMA IVD and/or companion diagnostic submissions (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 preferred. • Proven ability to act as the primary FDA-facing regulatory lead, work cross-functionally, and communicate clearly with technical and business stakeholders.

🏖️ Benefits

• health benefits • 401K • access to professional development resources • learning and development programs