Ashley Reynolds Schneider
Regulatory Affairs Manager @Baxter International Inc.
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WORK HISTORY
Regulatory Affairs Manager @Baxter International Inc.
Responsible and accountable for defining global operational regulatory strategies and preparing USA and EU submissions in support of existing marketing authorizations for infusion pumps, interfacing with key business and cross-functional stakeholders to ensure that the commercial objectives are achieved. Within the Medication Delivery/Fluid Systems Regulatory Team be accountable for the relationship with the US Food and Drug Administration and Notified Body for assigned products. Provide input and help influence global regulatory strategies and be responsible for the execution of Baxter’s regulatory initiatives.Responsibilities-Develop and execute regulatory plans for infusion pumps, infusion pump platforms and connected devices for new and sustaining devices. Obtain marketing authorizations for assigned regions and support local country submissions. Develop sound regulatory decisions and justifications- Identify and prioritize key areas of risk and implement mitigation plans-Monitor applicable regulatory requirements; assure compliance with internal and external standards-Represent and lead the RA function for infusion pump portfolio of products-Perform gap analysis on regulatory documentation and propose solutions and/or identify areas of improvement-Prepare and submit pre-subs, 510(k)s according to FDA guidelines-Create and maintain EU STED and Declaration of Conformity Files according to MDR-Review SOP\'s for compliance with Global regulations
EDUCATION
San Diego State University
Master's Degree, Regulatory Affairs (Capstone Project: Orphan Drug Development)
California State University San Marcos
Certificate, Lab Safety Seminar
California State University San Marcos
Certificate, Biotechnology Lab Tech
Vista High School
High School
University of California, Riverside
B.S. Biology, Biology/ Biological Science
SKILLS
ABOUT ASHLEY REYNOLDS SCHNEIDER
Quality and Compliance focused Regulatory Affairs Professional passionate about Medical Devices and Scientific advancement that directly impacts quality of life. Education Snapshot- B.S. in Biology (Cellular/Molecular focused) from University of California, Riverside 2009- M.S. Regulatory Affairs from SDSU; Capstone Project on Orphan Drug Development and Impact, Advisor Joyce Williams. 2014- Project Management for Regulatory Professionals, RAPS, 2017- EU Medical Device Regulation training via Emergo Group- 2021Personal Development-Toastmasters International- Competent Communicator (Public Speaking)- Leader, Diversity and Inclusion CouncilAreas of interest-Medical Device Hardware- Software As/In Medical Device- Quality and Risk Management- Program/Product Development
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