Cindy Kha
Regulatory Affairs | Clinical Affairs | Quality Systems
- Role
- Senior Regulatory Affairs Specialist at Nexpring Health
- Location
- Orange County, CA, US
- LinkedIn followers
- 500 followers
About Cindy Kha
Over my career, I\'ve focused on getting medical devices to market and been involved in FDA premarket subs and EU MDR technical doc for CE marking. I love a good regulatory challenge so if you have one, let\'s discuss!• Lead author for 510(k) submissions:(1) K233764,(2) K241341,(3) K250445• Successfully obtained EU MDR CE marked certifications• Certified ISO 13485:2016 Certified Lead Auditor• Notary Public• Role within Regulatory and Clinical Affairs team for new product development/sustaining and premarket submissions. • Biocompatibility SME• Authored/collaborated on technical documents: e.g, Biocompatibility Evaluation, Risk Management, Hazard Analysis, FMEAs, Clinical Evaluations, HHE, labelings, etc. • Experiences in assisted reproductive technology (ART), andrology, IVF products; and laparoscopic ports and instruments• Research experience in the field of stem cell and eye regenerative medicine, immunology, and toxicology
Experience
Senior Regulatory Affairs Specialist
Mar 2026 — Present · Irvine, CA, US
Education
University of Nevada-Las Vegas
Master of Science - MS, Biological Sciences, Cell and Molecular Biology
University of Nevada-Las Vegas
Doctor of Philosophy (Ph.D.), Biological Sciences, Integrative Physiology
University of California, Riverside
Bachelor of Science (B.S.), Neuroscience
California State University, Los Angeles
Master of Science (M.S.), Biology, Neuroscience
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