Connor McCarty
Regulatory Affairs @ Intuitive
- Role
- Sr Regulatory Engineer at Intuitive
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
Experience
Sr Regulatory Engineer
Jan 2020 — Present · Washington, DC, US
Authored Traditional and Special 510k submissions and MDR technical files for the da Vinci SP surgical system, robotic control software, and articulated endoscope. Achieved initial European CE Mark approval for the SP system. Led successful FDA clearances: K202968, K210918, K211595, K211316, K212747, K212101, K231798, K232773.
Education
Tsinghua University
Research Assistant, Bioinformatics Division, Department of Automation
2008
Peking University
Research Assistant, MEMS Research Center, Institute of Microelectronics
2010
University of Southern California
BS, Biomedical Engineering
2006 — 2010
Cate School
High School
2002 — 2006
University of Southern California
MS, Medical Device and Diagnostic Engineering
2010 — 2011
Skills
- Technical Files
- Matlab
- Regulatory Strategy Development
- Fda
- Combination Products
- Medical Devices
- Post Market Surveillance
- Ce Marking
- Neurosurgery
- Medical Device Directive
- Cross-Functional Team Leadership
- Product Launch
- Biomedical Engineering
- Product Development
- Product Management
- Regulatory Filings
- Dossiers
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