Pengsheng Shane Chen
Senior Regulatory Affairs Specialist (Class III/AIMD) | Global Regulatory Strategy, Evidence Architecture, Compliance, and Registration
- Role
- Sr Regulatory Affairs Specialist, Tmtt at Edwards Lifesciences
- Location
- Ontario, CA, US
- LinkedIn followers
- 500 followers
About Pengsheng Shane Chen
In the high-stakes domain of Class and Active Implantable Medical Devices (AIMD), I view Regulatory Strategy as the critical link between innovation and patient safety.My core competency is architecting the chain of evidence. I ensure a seamless logic flow from Commercial Goals to Product Claims, anchored by Scientific Substantiation. I move beyond simple submission execution to establish rigorous traceability frameworks, ensuring that accuracy serves as a form of patient care.My strategic focus:1. Defensibility: Building audit-ready evidence chains that withstand global scrutiny, safeguarding patient well-being.2. Efficiency: Optimizing the balance between compliance costs and commercial timing to accelerate patient access to life-saving technologies (US, EU, APAC).
Experience
Sr Regulatory Affairs Specialist, Tmtt
Nov 2025 — Present · Irvine, CA, US
Education
University of Southern California
Master's degree, Regulatory Science and Medical Product Quality
2018 — 2019
Taipei Medical University
Bachelor of Science (B.Sc.), Dental technology
2007 — 2012
University of Southern California
Graduate Certificate, Regulatory and Clinical Affairs
2018 — 2018
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