Overview
An experienced FDA Regulatory Attorney is sought to serve as the primary FDA-facing regulatory lead for a Fortune 500 clinical laboratory client. This role requires deep, hands-on expertise in Class III PMA in vitro diagnostic (IVD) and companion diagnostic products. The attorney will drive strategy and execution for complex submissions and lifecycle management, collaborating closely with cross-functional and partner teams.
Responsibilities
- Lead FDA regulatory strategy and execution for Class III PMA IVDs and companion diagnostics, including lifecycle PMA planning and post-approval changes.
- Manage strategy, drafting, and submission of Modular PMAs, full PMAs, PCCPs, Q-Subs, SIRs, and related regulatory filings.
- Serve as the main interface with FDA/CDRH: lead meetings, negotiate positions, and draft responses to FDA requests for additional information.
- Provide advice on pre- and post-approval requirements such as quality systems, risk management, medical device reports (MDRs), labeling, and other post-market obligations.
- Support product classification and premarket strategies for 510(k)-regulated IVDs, including preparation of Q-Subs.
- Collaborate with cross-functional teams including business development, commercial, R&D, quality, manufacturing, legal, and regulatory to align regulatory and business objectives.
- Develop and deliver training on FDA regulation of medical devices and IVDs, covering approvals, clearances, and enforcement topics.
Requirements
- Juris Doctor (J.D.) degree and active license to practice law in at least one U.S. jurisdiction.
- Minimum of five years of in-house experience at a medical device or diagnostics company preferred.
- Direct ownership and hands-on experience with Class III PMA IVD and/or companion diagnostic submissions, including strategy, drafting, and FDA interaction.
- Recent 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 is preferred.
- Proven ability to act as the primary FDA-facing regulatory lead and communicate effectively with both technical and business stakeholders.
Compensation & Benefits
- Estimated total compensation for full-time attorney roles ranges from $104,500 to $325,000 per year.
- Compensation is determined based on factors including experience, skills, certifications, location, and business needs.
- Additional benefits may include health, dental, and vision insurance; paid holidays and paid time off; flexible work arrangements; and professional development opportunities.
Location
This position supports a Fortune 500 clinical laboratory and may involve collaboration with multiple teams; specific location details are not provided.