Principal Regulatory Affairs Specialist (Hybrid – Orange County, CA)
Overview
We 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 Responsibilities
- Lead regulatory strategy development for Class III catheter-based products (e.g., cardiovascular, neurovascular, or interventional systems)
- Author and manage FDA submissions including:
- IDEs
- PMAs / PMA Supplements
- Pre-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 responses
- Support clinical trial strategy and regulatory alignment
- Assess design changes, risk, and labeling for regulatory impact
- Ensure compliance with:
- FDA 21 CFR Part 820
- ISO 13485 / ISO 14971
- Mentor junior regulatory team members and provide technical guidance
Qualifications
- 8–12+ years of Regulatory Affairs experience in medical devices
- Strong experience with Class III devices (catheter-based preferred)
- Proven track record with:
- PMA submissions and approvals
- IDE submissions and clinical support
- Deep understanding of:
- FDA regulatory pathways
- EU MDR / global submissions
- Experience interacting directly with regulatory agencies
- Strong technical writing and submission leadership experience
- Background in cardiovascular, electrophysiology, or minimally invasive devices preferred
What Makes This Role Compelling
- Work on next-generation catheter technologies in a clinical-stage or commercial environment
- High visibility role with direct impact on regulatory approvals and market entry
- Opportunity to shape regulatory strategy from development through commercialization
- Hybrid flexibility in a strong Orange County medtech hub
