Aleksey Y.
Senior Regulatory Affairs (Wireless Scope) Global Product Quality @Baxter International Inc.
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WORK HISTORY
Senior Regulatory Affairs (Wireless Scope) Global Product Quality @Baxter International Inc.
DE
Regulatory affairs (wireless scope) Global product quality. Integration wireless modules WLAN/BT /short range, wireless changer to the medical hosts. Product design review, testing strategy, applied standard list, risk assessment review, IFU, coexisting testing FDA/FCC/RED and BT qualification scopes.Design control /input /output during product development NPD and sustaining process. Collaboration for the product releasing process. SAP operation as product documentation storage, document review and QM tool.Collaboration: in releasing cardiology product lines, hearing screeners, vision portfolio, and operation lighting with wireless components.Evaluation as subject matter expert (SME) materials from the regulatory intelligence program regarding validation and application national and international standards updates. Supporting management in providing regulatory support to execute on the finalized Geo-Expansion list for GRL Portfolios, for wireless certifications. Support compliancy for product wireless Portfolio.Define a proposed future state for the Global Radio Team building. Support the needful wireless approvals, NPD and sustaining projects for the various upcoming R&D projects as needed. Managing product compliancy database and knowledge management system.(wireless scope). interfacing with regulatory agencies and conformity assessment bodies (UL, TUV, Intertek, CSA )
EDUCATION
National Technical University of Ukraine 'Kyiv Polytechnic Institute'
Master/Dipl ing, Wiress., Radio engineering
National Technical University of Ukraine 'Kyiv Polytechnic Institute'
Master/ Diplom Engeneer , Wireless/Radio/Electrical engeneer
ABOUT ALEKSEY Y.
Key expertise includes: Capturing and verifying product compliance requirements…
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