John Czyzewicz
Senior Regulatory Affairs Specialist @Ert
Medford, MA, US
EMAILS
MOBILE NUMBERS
+91 *********19
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WORK HISTORY
Mar 2018 — Present
Senior Regulatory Affairs Specialist @Ert
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Oversee compliant use of mobile and handheld devices used in pharmaceutical clinical trials in over 90 countries. Provide regulatory expertise concerning testing, trade compliance, supply chain, and import and export requirements. Manage compliance strategy of medical and non-medical devices/solutions. Review and provide gap-analyses of technical documentation and regulatory changes. Provide regulatory assessments for NPI and OEM projects, with some Design Assurance duties.
SKILLS
Wireless NetworkingAtm NetworksIsdnEmbedded SystemsCellular CommunicationsFirmwareUlIpv6Systems EngineeringProduct DevelopmentSix SigmaFccElectrical EngineeringBusiness DevelopmentCe MarkingIntegrationLteRoutersAgile MethodologiesLinuxH.323Tcp/IpTelecommunicationsRegulatory AffairsSoftware DevelopmentTeam LeadershipQuality AssuranceCloud ComputingHardware ArchitectureProgram ManagementSoftware EngineeringPerlUnified CommunicationsMedical DevicesRohsStrategic PlanningSwitchesValidationWirelessWifi
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