Axiom

Where legal teams can find the right talent for everything from routine in-house tasks to complex outside counsel work.

FDA Regulatory Attorney – Class III IVD, Companion Diagnostics

AttorneyAttorneyFull TimeRemoteSeniorTeam 1,001-5,000Since 2000H1B SponsorCompany Site LinkedIn

Location

United States

Posted

65 days ago

Salary

$150K / year

Seniority

Senior

Professional Certificate5 yrs expEnglish

Job 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.

Job 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.