Robert Young
Regulatory Affairs Associate at LifeHealthcare- Claim this Profile
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Bio
Experience
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LifeHealthcare
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Australia
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Medical Equipment Manufacturing
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400 - 500 Employee
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Regulatory Affairs Associate
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Sep 2021 - Present
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LMT Surgical
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Australia
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Medical Equipment Manufacturing
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1 - 100 Employee
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QA/RA/Tenders Coordinator
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Jul 2017 - Sep 2021
Coordinating the regulatory requirements with TGA, PL, Medsafe, Poisons, along with maintaining the ISO 9001 accreditation as well as tender application and contract management. Coordinating the regulatory requirements with TGA, PL, Medsafe, Poisons, along with maintaining the ISO 9001 accreditation as well as tender application and contract management.
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VWR INTERNATIONAL
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United States
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200 - 300 Employee
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Regulatory Affairs & Quality Assurance Officer
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Sep 2016 - Jul 2017
Manage and operate the regulatory affairs and quality assurance for VWR International within the Australian market. Looking after all compliance with regulation for import, supply and management of poisons and drugs, medical devices and IVDs, electrical safety and electromagnetic compliance, refrigerant gases, defence strategic goods. Investigation or regulatory requirements and risk assessment on these requirements for new business opportunities. Establishing systems to incorporate requirements in to business processes to maintain compliance as well as day to day monitoring, assessing and reporting.Additionally I look after the day today management of the quality management system under ISO 9001. This includes monitoring documents, updating procedures with appropriate staff, auditing and reporting to senior management.
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Intertek
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United Kingdom
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International Trade and Development
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700 & Above Employee
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Trade Services Manager
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Jan 2016 - Jun 2016
Management of multiple teams to progress work to completionBusiness DevelopmentCustomer Service support and salesProblem solvingProject managementManaging laboratory, office and externally located staffCo-ordinating contractors to provide correct requirementsMonitoring, correlation and statistical analysis of resultsMethod investigation, rationalization and developmentCo-ordination of inspection requirements for Australia and internationallyDatabase management and operation
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Technical Manager
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Aug 2011 - Nov 2015
Customer Service support and salesProblem solvingProject managementManaging laboratory, office and externally located staffCo-ordinating contractors to provide correct requirementsMonitoring, correlation and statistical analysis of resultsMethod investigation, rationalization and developmentCo-ordination of inspection requirements for Australia and internationallyDatabase management and operation Customer Service support and salesProblem solvingProject managementManaging laboratory, office and externally located staffCo-ordinating contractors to provide correct requirementsMonitoring, correlation and statistical analysis of resultsMethod investigation, rationalization and developmentCo-ordination of inspection requirements for Australia and internationallyDatabase management and operation
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Senior Research Officer- Sorghum Breeding
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Mar 2010 - Jun 2011
Collaboration with farmers and producersIndustry researchReport preparationNursery and trial design, set up and operationBreeding operations.Breeding database management and operationMaintenance of greenhouse plantsPedigree CrossingHybrid Seed developmentSeed storage, preparation and planting Collaboration with farmers and producersIndustry researchReport preparationNursery and trial design, set up and operationBreeding operations.Breeding database management and operationMaintenance of greenhouse plantsPedigree CrossingHybrid Seed developmentSeed storage, preparation and planting
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Education
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The University of Queensland
Agricultural Science, Plant and Soil Science