Principal Regulatory Specialist

Principal Regulatory Affairs Specialist (Hybrid – Orange County, CA)OverviewWe are seeking a Principal Regulatory Affairs Specialist to lead global regulatory strategy and execution for Class III, catheter-based medical devices. This is a high-impact, hands-on role supporting IDE/PMA submissions, clinical strategy, and commercialization efforts in a fast-paced, cross-functional environment.This position follows a hybrid model based in Orange County, CA.Key ResponsibilitiesLead regulatory strategy development for Class III catheter-based products (e.g., cardiovascular, neurovascular, or interventional systems)Author and manage FDA submissions including:IDEsPMAs / PMA SupplementsPre-submissions (Q-Subs)Drive global regulatory strategy (US, EU MDR, ROW submissions)Act as the regulatory lead on cross-functional teams (R&D, Clinical, Quality, Manufacturing)Interface directly with FDA and Notified Bodies, including meeting preparation and responsesSupport clinical trial strategy and regulatory alignmentAssess design changes, risk, and labeling for regulatory impactEnsure compliance with:FDA 21 CFR Part 820ISO 13485 / ISO 14971Mentor junior regulatory team members and provide technical guidanceQualifications8–12+ years of Regulatory Affairs experience in medical devicesStrong experience with Class III devices (catheter-based preferred)Proven track record with:PMA submissions and approvalsIDE submissions and clinical supportDeep understanding of:FDA regulatory pathwaysEU MDR / global submissionsExperience interacting directly with regulatory agenciesStrong technical writing and submission leadership experienceBackground in cardiovascular, electrophysiology, or minimally invasive devices preferredWhat Makes This Role CompellingWork on next-generation catheter technologies in a clinical-stage or commercial environmentHigh visibility role with direct impact on regulatory approvals and market entryOpportunity to shape regulatory strategy from development through commercializationHybrid flexibility in a strong Orange County medtech hub