Michelle Willis Email & Phone Number
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Michelle Willis Location
- Aliso Viejo, CA, US
Michelle Willis Work
- Independent Consultant, Medical Devices (June 2023 - Present)
- Senior Director, RA and QA @ (May 2022 - May 2023)
- Senior Director Regulatory Affairs @ (April 2021 - May 2022)
- Director of Regulatory Affairs @ (January 2018 - April 2021)
- Quality and Regulatory Consultant @ WILLIS MEDICAL (June 2016 - November 2017)
- Director of Regulatory Affairs @ (July 2015 - June 2016)
- Director Of Regulatory Affairs @ (July 2013 - June 2015)
- Senior Manager, Regulatory Affairs @ (July 2011 - June 2013)
- Manager, Regulatory Affairs @ (June 2008 - July 2011)
- Supervisor, Regulatory Affairs @ (January 2006 - June 2008)
- Senior Regulatory Affairs Specialist @ Medtronic (June 2004 - January 2006)
- Regulatory Affairs Specialist @ (August 2002 - June 2004)
- Associate Regulatory Affairs Specialist @ (May 1999 - August 2002)
Michelle Willis Education
- University of Memphis
Bachelor of Business Administration (Marketing and Sales)
Michelle Willis Skills
- 21 CFR
- 510 K
- 510(k)
- Analytical Skills
- CAPAs
- CE marking
- Class II
- Class III Medical Devices
- Commercialization
- Communication
- Corrective and Preventive Action (CAPA)
- Cross-functional Collaborations
- Cross-functional Coordination
- Cross-functional Team Leadership
- Defining Requirements
- European Union
- Exit Strategies
- Global Strategy
- International Regulations
- International Standards
- Knowledge Sharing
- Leadership
- Market Access
- Notified Body correspondence
- Organizational Leadership
- People Development
- Personnel Management
- Problem Solving
- Product Labeling
- Quality Management
- Regulatory Advice
- Regulatory Affairs
- Regulatory Agencies
- Regulatory Approvals
- Regulatory Audits
- Regulatory Documentation
- Regulatory Filings
- Regulatory Projects
- Regulatory Strategy
- Remediation
- Risk Management
- Root Cause Analysis
- Software
- Teamwork
- U.S. Food and Drug Administration (FDA)
- Public Speaking
- Business Analysis
- Microsoft Word
- Business Development
Michelle Willis Summary
- Michelle Willis, based in Aliso Viejo, CA, US, is currently a Independent Consultant, Medical Devices at Self Employed. Michelle Willis brings experience from previous roles at uLab Systems, Inc. , BioHorizons, MicroPort Orthopedics, Inc. and WILLIS MEDICAL. Michelle Willis holds a Bachelor of Business Administration in Marketing and Sales @ University of Memphis. With a robust skill set that includes 21 CFR, 510 K, 510(k), Analytical Skills, CAPAs and more. Michelle Willis has 1 mobile phone numbers on RocketReach.
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