Derek de Vaul
Regulatory Affairs Specialist II | Submissions | Change Notifications | I help med device companies initiate clinical trials and receive marketing clearance or approval by managing submissions and FDA communications
- Role
- Regulatory Affairs Specialist Ii at Stryker
- Location
- Irvine, CA, US
- LinkedIn followers
- 500 followers
Experience
Regulatory Affairs Specialist Ii
Sep 2025 — Present · Irvine, CA, US
Supports Stryker Inari Division’s regulatory submissions, QMS integration, and lifecycle management activities for global Class II and medical devices during post-acquisition integration of Stryker and legacy Inari Medical systems (Windchill onePLM and more).• Leads regulatory affairs QMS integration activities following Stryker’s acquisition of Inari Medical, Inc.• Authored a global regulatory affairs plan for the change of the legal manufacturer driven by acquisition• Prepares regulatory submissions and technical documentation updates to capture design changes• Maintains compliance with CE marking, EU MDR, and EUDAMED requirements by managing procedure updates• Supports advertising/promotion system migration and provides regulatory guidance for cross-functional projects
Education
Northeastern University
Master of Science - MS, Regulatory Affairs
Saddleback College
A.S., Chemistry
2015 — 2017
California State University, Fullerton
B.S., Biochemistry
2017 — 2019
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