Nick Cora Email & Phone Number
Regulatory Affairs Manager @ Antech Diagnostics
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Nick Cora Location
- Longmont, CO, US
Nick Cora Work
- 2024 -now Regulatory Affairs Manager @
- 2023 -2024 Sr. Regulatory Affairs Specialist @
- 2022 -2022 Principal, Regulatory Affairs Specialist @
- 2021 -2022 Regulatory Affairs Specialist @
- 2017 -2021 Regulatory Affairs Principal @
- 2008 -2017 Validation Engineer @
- 2006 -2008 Senior Validation Specialist @
- 2004 -2006 Quality Specialist @
- 1999 -2004 QC Analyst @ PR Pharmaceuticals
Nick Cora Education
- Portland State University
Master of Engineering - MEng (Systems Engineering)
2011-2014 - Regis University
Master of Computer Applications - MCA (Information Technology)
2001-2004 - Colorado State University
Bachelor of Science - BS (Biology/Biological Sciences, General)
1992-1997
Nick Cora Skills
- Strategy Creation
- Regulatory Strategy
- Regulatory Requirements
- Regulatory Agencies
- Design Control
- Premarket Approval (PMA)
- ISO 13485
- Regulatory Submissions
- Good Laboratory Practice (GLP)
- Regulatory Affairs
- Engineering
- Quality Assurance
- European Union
- Product Development
- Technical Files
- Regulatory Filings
- Medical Devices
- In Vitro Diagnostics (IVD)
- Manufacturing
- Validation
- 21 CFR Part 11
- Computer System Validation
- CAPA
- FDA
- GxP
- Change Control
- Corrective and Preventive Action (CAPA)
- Pharmaceutical Industry
- Quality Control
- SOP
- U.S. Food and Drug Administration (FDA)
Nick Cora Summary
- Nick Cora, based in Longmont, CO, US, is currently a Regulatory Affairs Manager at Antech Diagnostics. Nick Cora brings experience from previous roles at Tosoh Bioscience, Inc., LumiraDx, DePuy Synthes and Roche Diagnostics. Nick Cora holds a 2011 - 2014 Master of Engineering - MEng in Systems Engineering @ Portland State University. With a robust skill set that includes Strategy Creation, Regulatory Strategy, Regulatory Requirements, Regulatory Agencies, Design Control and more. Nick Cora has 3 emails and 1 mobile phone numbers on RocketReach.
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