Jennifer Mascioli-Tudor
Founder and Principal Consultant @Jmt Compliance Consulting
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WORK HISTORY
Founder and Principal Consultant @Jmt Compliance Consulting
San Francisco, CA, US
JMT Compliance Consulting, LLC, is focused on helping organizations navigate the quality and regulatory affairs landscape and providing expertise in leadership coaching, mentoring and foundational business support and providing Fractional Executive COO/CQRO leadership to support growing businesses. Partnering with various Medical Device organizations to help establish, implement and/or optimize their Quality Management Systems (full product life cycle) across FDA Class I-Class Medical Devices (to include Non-MDDS Software products, SAMD Class I, Imaging Devices and Active Implantable Devices),Audit Readiness, QMS Training, Business and Quality Regulatory Strategy/Execution.I am excited to share the knowledge that I have gained in my 20+ years in the pharmaceutical and medical device spaces with new organizations, emerging enterprises and future partners. Please feel free to schedule a free initial consultation call so that we can talk more about your organizational needs.
EDUCATION
Eastern Michigan University
B.S., Physiology/Chemistry/French
University of Phoenix
MBA, Global Business Management
San Diego State University
Regulatory Affairs Courses
SKILLS
ABOUT JENNIFER MASCIOLI-TUDOR
Experienced Quality and Regulatory Executive Consultant With over 20 years of progressive experience in Medical Devices (Class I, Class II and AIMD, Capital Equipment Manufacturer, SAMD), Pharmaceutical, and Diagnostic industries, I bring a wealth of knowledge to support all stages of Medical Device companies. From Quality Assurance (QA) and Regulatory Affairs (RA) to leadership development, my expertise covers the full spectrum of industry needs.An out-of-the-box thinker, I have a proven track record of: Building strong, cohesive teams🧩 Solving complex problems⏱ Meeting deadlines while adapting to increasing responsibilities Coaching and mentoring staff🤝 Working effectively and building strong relationships with cross-functional teams Collaborating with regulatory bodies Mediating problems to resolution in a timely mannerI am passionate about driving organizational excellence and ensuring compliance across all stages of product development and commercialization. Whether it’s developing robust QA systems, navigating intricate RA requirements, audit readiness preparation, QMSR transition activities, QMS remediation activities, due diligence projects or building and leading teams to success, I am committed to supporting the growth and innovation of Medical Device companies. Let’s connect to discuss how I can help support compliance scale and growth initiatives for your organization. Please feel free to reach out to learn more: J•••••••@jmtcompliance.com Or schedule some time: https://lnkd.in/gbJF65pW
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