Regulatory Affairs LeadVirtualVocations • Gary, Indiana, United States
Regulatory Affairs Lead
VirtualVocations • Gary, Indiana, United States
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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
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Regulatory Lead • Gary, Indiana, United States
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