Mike Preto Email & Phone Number
Director, Regulatory Affairs – Americas and ANZ @ ResMed
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Mike Preto Location
- Cleveland, OH, US
Mike Preto Work
- 2026 -now Director, Regulatory Affairs – Americas and ANZ @
- 2024 -now Principal Consultant @ North Coast Regulatory Solutions, LLC
- 2023 -2026 Regulatory Affairs Program Director - Strategic Regulatory Compliance @
- 2017 -2023 Regulatory Affairs Program Manager @
- 2015 -2017 Senior Manager, Regulatory Affairs - CT and AMI @
- 2011 -2015 Regulatory Affairs Specialist - Computed Tomography and Advanced Molecular Imaging @
- 2009 -2011 Regulatory Affairs Leader - MR @
- 2008 -2011 Product Safety Lead Engineer - Coils @
- 2008 -2009 QA Lead Engineer @
- 2003 -2008 Safety Team Leader @
Mike Preto Education
- Ohio University
Bachelor of Science (IEEE, ACM)
1997-2003 - St. Edward High School 1993-1997
Mike Preto Skills
- IEC 60601-1
- 510(k) Submissions
- MDD
- IEC 60601
- CAPA
- Medical Device Directive
- ISO 13485
- Design Control
- Medical Devices
- FDA
- CE marking
- Quality System
- Quality Assurance
- Testing
- Regulatory Affairs
- ISO 14971
- Regulatory Requirements
- ISO
- Cross-functional Team Leadership
- V&V
- Software Documentation
- Biomedical Engineering
- Validation
- Manufacturing
- R&D
- Product Development
- Quality Auditing
- GMP
- Research
- Regulatory
- AMI
- Microsoft Office
- Clinical Trials
- Training
- Iec 60601 1
- 510k Submissions
- Cross Functional Team Leadership
- 510 Submissions
Mike Preto Summary
- Mike Preto, based in Cleveland, OH, US, is currently a Director, Regulatory Affairs – Americas and ANZ at Resmed. Mike Preto brings experience from previous roles at North Coast Regulatory Solutions, LLC, Philips and Accuray. Mike Preto holds a 1997 - 2003 Bachelor of Science in IEEE, ACM @ Ohio University. With a robust skill set that includes IEC 60601-1, 510(k) Submissions, MDD, IEC 60601, CAPA and more. Mike Preto has 2 emails and 1 mobile phone numbers on RocketReach.
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