Axiom · 2 weeks ago
FDA Regulatory Attorney – Class III IVD / Companion Diagnostics
United States
Full-time
Remote
Senior Level
$104K/yr - $325K/yr
5+ years expAxiom is a leader in alternative legal services, seeking an experienced FDA Regulatory Attorney with expertise in Class III PMA in vitro diagnostic products. The role involves leading FDA regulatory strategy and execution, managing complex submissions, and collaborating with cross-functional teams to align regulatory and business goals.
LegalConsultingGovernmentProfessional ServicesComplianceLaw Enforcement
No H1B
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 (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
Qualification
Required
J.D. and active license to practice law in at least one U.S. jurisdiction
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
Preferred
At least five years of in-house experience at a medical device or diagnostics company is preferred
Familiarity with 510(k) pathways for IVDs preferred
Benefits
Health, dental, and vision insurance
Paid holidays and PTO
Flexible work arrangements
Professional development opportunities and tools
Company
Axiom
As the leading alternative legal services provider globally, Axiom gives in-house legal teams on-demand access to top legal talent and lawyers — deployed when, where, and how clients need it, for up to 50% less than national law firms.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$28MKey Investors
Permira
2019-09-06Corporate Round
2013-02-06Series Unknown· $28M
Leadership Team
David McVeigh
Chief Executive Officer
Eric Bouchard
Chief Financial Officer
Recent News
2026-07-10
Company data provided by crunchbase