Regulatory Affairs Lead

A company is looking for a Regulatory Affairs Lead, IND / IDE.

Key Responsibilities

Advise on regulatory pathways, product classification, and study design considerations

Lead FDA engagement and manage original and maintenance submissions under 21 CFR 312 / 812

Establish and maintain SOPs, mentor regulatory staff, and ensure audit / inspection readiness

Required Qualifications

Advanced degree in a relevant field or equivalent experience

Minimum eight years of progressive regulatory affairs experience with a focus on IND / IDE submissions

Deep knowledge of 21 CFR 312 / 812, ICH-GCP, and familiarity with device quality systems

Experience within an academic medical center or complex research environment

Exceptional technical writing and project management skills