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Administrative & Secretarial

Other - Admin Support

From a Regulatory perspective:--Initial regulatory requirements analysis for new markets (EU, Brazil, Australia, US, Canada, etc.)--Identification of applicable test protocols (ISO standards, etc.) and management of test houses--Interfacing with regulatory agencies and identifying consultants--Writing of regulatory submissions such as FDA 510(k)s--Quality System development and implementation to required standards (ISO 13485, FDA, CMDCAS, etc.)From a Project perspective:--Using good interpersonal skills to keep people motivated and excited--"Conducting the orchestra", developing a logical rhythm of events and ensuring timely completion of tasks--Turning "unknown unknowns" into "known unknowns", forseeing problems before they arise and altering the "orchestra" accordingly--Coordination of teams on an international level--Intelligently focusing energy on tasks with the highest variability, including procurement of additional expertise as necessaryFrom a Product perspective:--Development

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$5/hr Ongoing

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From a Regulatory perspective:--Initial regulatory requirements analysis for new markets (EU, Brazil, Australia, US, Canada, etc.)--Identification of applicable test protocols (ISO standards, etc.) and management of test houses--Interfacing with regulatory agencies and identifying consultants--Writing of regulatory submissions such as FDA 510(k)s--Quality System development and implementation to required standards (ISO 13485, FDA, CMDCAS, etc.)From a Project perspective:--Using good interpersonal skills to keep people motivated and excited--"Conducting the orchestra", developing a logical rhythm of events and ensuring timely completion of tasks--Turning "unknown unknowns" into "known unknowns", forseeing problems before they arise and altering the "orchestra" accordingly--Coordination of teams on an international level--Intelligently focusing energy on tasks with the highest variability, including procurement of additional expertise as necessaryFrom a Product perspective:--Development

Skills & Expertise

AnalysisDesignDraftingEngineeringInternationalInterpersonal SkillsManagementMarketingRequirements AnalysisSalesSupplier IdentificationTestWriting

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