---
bio: "Authentic regulatory professional who collaborates to gain the trust and respect\
  \ of teammates and cross-functional stakeholders to achieve solid regulatory strategies\
  \ and submissions. Experienced in submissions of low to moderate-high risk devices,\
  \ and recognized as an expert in clinical decision support, mobile medical applications,\
  \ digital health solutions and  \nAI/ML-enabled software. Experienced in collaborating\
  \ between internal regulatory affairs departments and external vendors in support\
  \ of product development, integration, product launch, premarket submissions/registrations\
  \ and post-market compliance. Passionate about leveraging self- and team-expertise\
  \ to provide direction to businesses, and proactively share  \nbest practices, creative\
  \ strategies and regulatory knowledge. Balances regulatory and business risks to\
  \ accelerate best in class solutions to market, and total product lifecycle solutions\
  \ to improve lives."
credentials: []
hire_date: '2026-09-21'
hobbies: Family time, skiing, biking, reading, gardening (including vegetables)
linkedin: null
name: Alex Friedman
order: null
photo: /img/people/Alex_Friedman-3e2bd5b7a754801f9337c9579b89aff6.jpg
skills: Regulatory Strategies \| Software as a Medical Device (SaMD) \| Cloud-based
  \|Artificial Intelligence (AI) \| Machine Learning (ML) \| Cybersecurity \| FDA
  Submissions \| Regulatory Intelligence and Research \| Guidance documents assessments
  \| Compliance \| Post-market surveillance \| ISO 13485 \| ISO 14971 \| AAMI TIR34971
  \| SOC 2 \|IEC 62304 \| IEC 60601 \| Labeling reviews \| Planning and Project Management
  \| Regulatory Intelligence \| Leadership \| Presentations \| Training \| Collaboration
  \| Cross-functional teaming \| Consensus building \| Creative problem solving \|
  EU MDR Technical Filing
suffix: []
summary: ''
testimonials: []
title: Senior Regulatory Affairs Specialist
---