Rene' Hardee Email & Phone Number
Director of Business Development and Client Experience @ MedSec
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Rene' Hardee Location
- Rockledge, FL, US
Rene' Hardee Work
- Director of Business Development and Client Experience @ (February 2025 - Present)
- Director of Regulatory and Program Management @ (January 2023 - February 2025)
- Sr. Manager Regulatory Affairs @ (January 2023 - May 2023)
- Regulatory Affairs Manager @ (August 2020 - January 2023)
- Sr. Global Regulatory Affairs Compliance Specialist @ (April 2018 - August 2020)
- Sr. Regulatory Affairs Specialist @ (April 2016 - April 2018)
- Regulatory Affairs Specialist @ (April 2015 - April 2016)
- Quality Specialist @ (September 2011 - April 2015)
- Associate Project Manager @ (January 2011 - September 2011)
- Research Assistant @ (December 2008 - January 2011)
- Crossfit Level 1 Trainer @ Harbor City Crossfit (November 2010 - April 2015)
- Data Reduction Analyst Professional @ Computer Sciences Raytheon (June 2005 - October 2008)
Rene' Hardee Education
- Vanderbilt University
MS (Physics)
2000-2003 - Florida Institute of Technology
BS (Astrophysics)
1996-2000 - Florida Institute of Technology
Rene' Hardee Skills
- FDA
- 21 CFR 820/QSR
- 21 CFR 803/MDR
- 21 CFR 806/Recall
- ISO 13485
- CAPA
- Medical Devices
- Quality System
- Corrective Actions
- Preventive Actions
- Trend Analysis
- Root Cause Analysis
- Process Improvement
- Continuous Improvement
- Cross-functional Team Leadership
- Quality Assurance
- Risk Assessment
- Quality Auditing
- Internal Audit
- Compliance
- R&D
- V&V
- Requirements Analysis
- Manufacturing
- Iso 9000
- Cost of Quality
- Kaizen
- Training
- 5 Why
- Quality Management
- Design Control
- ASQ Member
- Integration
- 5 Whys
- Data Analysis
- Leadership
- Medical Imaging
- Supplier Quality
- Team Leadership
- Technical Writing
- Validation
- Lean Manufacturing
- Corrective and Preventive Action (CAPA)
- Research and Development (R&D)
- U.S. Food and Drug Administration (FDA)
- Verification and Validation (V&V)
- Business Process Improvement
- PowerPoint
- Microsoft Excel
- Cross Functional Team Leadership
- Business Trainings
- Branding Solution
- Information Technology
- Technical Trainings
- Social Media
- Verification and Validation V&V
- Corrective and Preventive Action Capa
- Research and Development R&d
- u.s. Food and Drug Administration Fda
- Research and Development
- u.s. Food and Drug Administration
- Verification and Validation
- Corrective and Preventive Action
Rene' Hardee Summary
- Rene' Hardee, based in Rockledge, FL, US, is currently a Director of Business Development and Client Experience at MedSec. Rene' Hardee brings experience from previous roles at MedSec and Hologic, Inc.. Rene' Hardee holds a 2000 - 2003 MS in Physics @ Vanderbilt University. With a robust skill set that includes FDA, 21 CFR 820/QSR, 21 CFR 803/MDR, 21 CFR 806/Recall, ISO 13485 and more. Rene' Hardee has 3 emails and 5 mobile phone numbers on RocketReach.
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