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.

Key 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.

Qualifications:
- 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.
- P

📌 FDA Regulatory Attorney – Class III IVD (Nuevo León)
🏢 Trellis Group
📍 Nuevo León