Alex Friedman
Regulatory Affairs Professional
- Role
- Regulatory Affairs Program Manager Digital Strategy at Olympus Corporation
- Location
- Pittsburgh, PA, US
- LinkedIn followers
- 500 followers
About Alex Friedman
I’m a regulatory professional passionate about advancing medical solutions that change lives. With expertise leading multidisciplinary teams, I generate strategies, submissions, and responses that get innovations into clinicians’ hands—safely and on time. Whether I’m researching regulatory pathways or presenting to the FDA, I thrive on turning complex challenges into clear solutions.What drives me? Knowing our work helps clinicians and patients, like my sibling who benefits from a technology I supported. I’ve led projects like regulatory support for AI-powered Clinical Decision Support software—hearing experts say they’d use it in their practice as soon as it is available is a great motivator—and for an implant for sleep disorders, navigating FDA discussions to sharpen the path forward for these solutions. Artificial intelligence is reshaping healthcare, and I’m excited to help balance innovation with public safety. History offers insight into the future, so I wrote a paper on Clinical Decision Support regulation—please take a look here:
Experience
Regulatory Affairs Program Manager Digital Strategy
Jun 2025 — Present
Education
Binghamton University
Bachelor of Science - BS, Applied Physics
University of Pennsylvania
Doctor of Philosophy - PhD, Bioengineering
Skills
- Life Sciences
- Biotechnology
- Medical Devices
- Capa
- Iso 13485
- Fda
- Regulatory Affairs
- Lifesciences
- Product Development
- Cross-Functional Team Leadership
- Design Control
- R&D
- Quality System
- Quality Assurance
- Manufacturing
- Quality Management
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