Genie Fuentespina
Director, Global Compliance and Regulatory Affairs @Beckman Coulter Diagnostics
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WORK HISTORY
Director, Global Compliance and Regulatory Affairs @Beckman Coulter Diagnostics
Brea, CA, US
Responsible for developing Regulatory Strategies for worldwide commercialization of in-vitro diagnostics. Responsible for optimizing regulatory processes through the development and implementation of software applications used for the management of the Global Regulatory Council, Product Regulatory Lifecycle, Field Actions, and Advertising and Promotional Materials. Responsible for leading a team of Global Process Owners (GPOs) for the following processes: Global Regulatory Council, Product Labeling Council, Field Actions, Environmental Compliance and Product Compliance Engineering. Served as Beckman Coulter Field Action GPO. Responsible for establishing Beckman Coulter corporate-wide strategy for IVDR implementation. Responsible for developing strategy of REACH compliance.
EDUCATION
Northwestern University - Kellogg School of Management
RAPs Executive Development Program, Regulatory Affairs
UC Irvine
Certificate of Undergraduate Studies, Product Development
University of Saint La Salle
BS, Chemical Engineering
University of St. La Salle
Bachelor of Science, Chemical Engineering
ABOUT GENIE FUENTESPINA
I am passionate about developing innovative compliance solutions and fostering professional growth within the regulatory field.25+ years of deep, diverse experience in Medical Device Quality and Regulatory Affairs. Dedicated to establishing and maintaining robust, compliant quality systems across global jurisdictions.Key Strengths:•Global Quality System Management: Development, implementation, and management of quality systems compliant with worldwide medical device regulations.•Regulatory Submissions & Strategy: Successful preparation and submission of FDA 513g and 510k filings and creation of comprehensive EU Technical Files (IVDR).•Compliance Remediation: Expertise in addressing FDA Warning Letters and managing Corrections and Removals.
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