Haewon P.
🌍 Global Regulatory Strategy & Compliance Leader | 📊 Process Optimization & Risk Management | 🤝 Driving Safe, Timely Market Access Across U.S. & Global Pathways
- Role
- Regulatory Affairs Manager at Hiossen
- Location
- Princeton, NJ, US
- LinkedIn followers
- 500 followers
About Haewon P.
Regulatory Strategy & Compliance LeaderI am a Regulatory Affairs professional with a PhD background and 5+ years of experience driving FDA 510(k) clearances, Q-Submissions, and EU MDR gap analyses. My career path has been unconventional—transitioning from scientific research into regulatory affairs later than most—but that journey has shaped me into a resilient, adaptable leader who thrives on solving complex challenges. Strategic Market Entry & Regulatory ApprovalsI specialize in identifying pathways that accelerate time-to-market without compromising compliance. From navigating FDA submissions to EU MDR compliance, I have translated complex requirements into actionable strategies that reduce risk and secure timely approvals. My expertise extends to SOP development, regulatory frameworks, and aligning cross-functional teams to achieve unified regulatory goals. Process Optimization & Risk ManagementI am passionate about transforming regulatory complexity into clarity. I have led process optimization initiatives—designing centralized tracking systems, leading risk management reviews, and implementing CAPA-driven remediations that safeguard product portfolios. These efforts not only close compliance gaps but also create scalable systems that support sustainable innovation and market success. Resilience & Global PerspectiveAs an immigrant professional who re-entered the workforce after a family career break, I bring a unique perspective shaped by adaptability, perseverance, and cultural agility. These experiences have strengthened my ability to collaborate across disciplines and geographies, enabling me to deliver both regulatory precision and business value. Areas of ExpertiseFDA 510(k) Submissions & Q-Sub StrategiesEU MDR Gap Analysis & Global ComplianceRisk Management, CAPA Oversight & Process OptimizationCross-Functional Alignment for Market Access🤝 Let’s Connect!If you’re seeking a results-driven regulatory leader who can ensure compliance, accelerate approvals, and build sustainable systems for growth, I’d welcome the opportunity to connect and exchange insights.
Experience
Regulatory Affairs Manager
Jan 2026 — Present · NJ, US
Education
Rutgers University
Certification in Pharmaceutical and Clinical Trials Management
2017 — 2020
Princeton University
Doctor of Philosophy - PhD, Geological and Earth Sciences/Geosciences
2002 — 2008
Princeton University
Doctor of Philosophy - PhD, Geological and Earth Sciences/Geosciences
Duke University Nicholas School of the Environment
Master's degree, Environmental Management
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.