Description
Skilled medical device regulatory affairs professional with extensive experience in quality assurance and clinical trial management, including Class III implantables and PMA devices. Six years with the FDA's Office of Device Evaluation. * Domestic and international regulatory affairs experience with a wide variety of devices ranging from disposables to Class III implants * Experienced in Quality System development
Work Experience
| COMPANY | POSITION HELD | DATES WORKED |
|---|---|---|
| Viveve Inc. | Director, Regulatory Affairs Regulatory Affairs Manager Consultant | 6/2019 - 6/2019 |
| Aesculap Implant Systems Llc | Director, Regulatory Affairs And Quality Assurance | 1/2006 - 1/2011 |
| Siemens Medical Solutions Inc. | Senior Manager, Regulatory Affairs | 1/2006 - 1/2006 |
| Animas Corporation | Director, Regulatory Affairs | 1/2006 - 1/2006 |
| Storz Instrument Company | Director, Clinical And Regulatory Affairs | 1/2006 - 1/2006 |
| Cooper Vision Cilco | Director Of Regulatory Affairs | 1/2006 - 1/2006 |
| Food And Drug Administration | Investigational Device Exemption Program Coordinator | 1/2006 - 1/2006 |
Accomplishments
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