Michael Aymami Email & Phone Number
Senior Director, Device Regulatory @ TriSalus Life Sciences
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Michael Aymami Location
- Boulder, CO, US
Michael Aymami Work
- 2022 - now Senior Director, Device Regulatory @
- 2020 - 2022 Director of Regulatory Affairs and Quality @
- 2018 - 2020 Regulatory Affairs and Quality Assurance Programs and Systems Director @ ArcherDX
- 2012 - 2018 Director Regulatory Affairs: Patient Monitoring and Recovery (Respiratory Interventions) @
- 2010 - 2012 Director RA, Compliance, and Technical Communications @
- 2006 - 2010 Global Director Regulatory and Quality @
- 2005 - 2006 R and D Project Manager @
- 2001 - 2005 Senior Global Program Manager @
- 1999 - 2001 NPI Program Manager @
- 1996 - 1999 Industrial Engineer @
Michael Aymami Education
- San Jose State University
Bachelor of Science (BS) (Industrial & Systems Engineering)
Michael Aymami Skills
- ISO 13485
- Medical Devices
- FDA
- Design Control
- Quality System
- R&D
- ISO 14971
- Regulatory Affairs
- V&V
- CAPA
- 21 CFR Part 11
- Regulatory Submissions
- ISO
- Validation
- Product Development
- Quality Assurance
- FMEA
- Quality Auditing
- Quality Management
- GMP
- Product Launch
- Sop
- Clinical Development
- Commercialization
- Process Simulation
- Root Cause Analysis
- Capital Equipment
- Change Control
- Pharmaceutical Industry
- Lean Manufacturing
- Market Development
- Technology Transfer
- Manufacturing
- Biomedical Engineering
- Design of Experiments
- Lifesciences
- Hardware Diagnostics
- Quality Control
- Iso 9000
- Minitab
- Auditing
- Continuous Improvement
- Regulatory Requirements
- DMAIC
- CE marking
- Clinical Trials
- SPC
- Biotechnology
- Cross-functional Team Leadership
- Supplier Quality
- Leadership
- Regulatory
- Solutions
- Process Improvement
- Strategy
- SAN
- Microsoft Excel
- Marketing
- Cross Functional Team Leadership
- Customer Service
- Peripheral Vascular
Michael Aymami Summary
- Michael Aymami, based in Boulder, CO, US, is currently a Senior Director, Device Regulatory at TriSalus Life Sciences. Michael Aymami brings experience from previous roles at TriSalus Life Sciences, ArcherDX and Medtronic. Michael Aymami holds a Bachelor of Science (BS) in Industrial & Systems Engineering @ San Jose State University. With a robust skill set that includes ISO 13485, Medical Devices, FDA, Design Control, Quality System and more. Michael Aymami has 2 emails and 1 mobile phone numbers on RocketReach.
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