Regulatory Affairs Specialist

Job ResponsibilitiesDetermine international regulatory submission and approval requirementsCompile, prepare, review regulatory submission with in-country representatives and ensure on-time submission to relevant authoritiesAnticipate regulatory obstacles and emerging issues throughout the product lifecycle and collaborate with management and cross-functional team to develop solutionsProvide regulatory input for responsible countries/region for product lifecycle planningMonitor applications under regulatory review, and communicate application progress to internal stakeholdersMonitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authoritiesIdentify emerging issues for responsible countries/regionAssess the acceptability of quality, preclinical and clinical documentation for submission filingProvide registration impact assessment in responsible countries/region for design changes throughout the product lifecycleOwnership of processes involved with maintaining annual licenses, registrations, listings in responsible countries/regionReview and approve advertising and promotional items to ensure regulatory compliance with intended marketsEnsure external communications for regulatory purposes meet regulationsRequirementsBachelor's degree (or Associate degree with 5+ years of relevant work experience)2+ years of related regulatory submission experience from a medical device, in vitro diagnostic device, and/or pharmaceutical industryFamiliar with relevant US/international regulatory requirements for medical devices including Quality Systems standardsProficient with MS Office suite (Word, Excel, Outlook, Powerpoint)Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization.