Jessica Montejo
Director Regulatory and Quality @Alma Lasers North America
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WORK HISTORY
Director Regulatory and Quality @Alma Lasers North America
Buffalo Grove, IL, US
Managed Regulatory and Quality Submissions for Alma Lasers North America, ensuring compliance for Aesthetic Devices, IPL, Lasers, RF, Lipo, Cosmetics, and Skincare with CBD.• Led FDA approval process for new product launches• Implemented quality control measures for enhanced product safety• Collaborated cross-functionally to achieve regulatory compliance and quality standards
EDUCATION
Rosalind Franklin University of Medicine and Science
Bachelor of Science (B.S.), Medical Technology- Clinical Laboratory Sciences 2006
Keller Graduate School of Management of DeVry University
MBA, Business
ABOUT JESSICA MONTEJO
As the Director of Regulatory and Quality at Alma Lasers North America, I manage regulatory and quality processes for aesthetic devices, including IPL, lasers, RF, and lipo. With over 10 years of experience in regulatory affairs, I have a proven track record of leading regulatory submissions for Class I, II, and medical devices, IVD, ASR, and advertising and promotion review for various medical devices.I hold a Bachelor of Science in Medical Technology- Clinical Laboratory Sciences from Rosalind Franklin University of Medicine and Science and certifications in Regulatory Affairs and Quality Management Systems Auditing. My skills include ISO 9001/ 13485, auditing, and medical technology. I am passionate about ensuring compliance, strategy, and planning for regulatory affairs and quality management systems across different regions, including the US, Latin America, Japan, and Canada.
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