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bio: I am a Regulatory Affairs Specialist with experience supporting the full lifecycle
  of software-as-a-medical device (SaMD), from regulatory strategy and development
  planning through design controls, submission, and design changes. I have guided
  SaMD products through FDA 510(k) clearance, EU CE marking, Health Canada licensing,
  and ANVISA notification. I have led front-room activities during MDSAP, ISO 13485,
  ISO/IEC 42001, and EU MDR notified body audits achieving compliance and successful
  audit outcomes. I hold an M.S. in Applied Biomedical Engineering from Johns Hopkins
  University and am passionate about helping bring safe, effective, and compliant
  healthcare technologies to patients.
credentials: []
hire_date: '2026-09-30'
hobbies: In my free time, I am a league bowler, dachshund mom, and former competitive
  Rubik's Cube solver who enjoys trying new sports and exploring local restaurants
  and coffee shops.
linkedin: null
name: Alese Devin
order: null
photo: /img/people/Alese_Devin-3e5bd5b7a75480139c4ccff92f893e7b.png
skills: AI/ML SaMD, 510(k), Project Management, ISO 13485, ISO 14971, Letter to File,
  Regulatory Strategy
suffix:
- MS
summary: ''
testimonials: []
title: Regulatory Affairs Specialist
---