**Sr. Regulatory Affairs Specialist** Requisition Number **2818** Location **US - Remote** State/Territory **General** **Summary** Experiencedprofessionalwhointegratesregulatoryknowledgethroughouttheproductlifecyclewithaspectsof effective management and strategy.This position supports the RA function by leading the coordination and preparation of global regulatory premarket submissions with an emphasis on US, EU, and Canada. **Essential Job Functions** + ·Support business growth bydeveloping go-to-market strategies for NPI and LCE projects; execute applicable registrations and action plans on time per project deadlines. + Represent regulatoryonmultidisciplinaryteamsandcommunicateregulatoryrequirementseffectively to cross-functional peers (e.g., clinical, global business unit, project management, quality). + Track submission review progress with related authorities (e.g., FDA) and work closely with relevant departments (internal and external) to drive reduction of submission review and approval cycle time. + Conductappropriateresearchtodevelopstrong, risk-basedregulatorystrategiesfornewproducts. + Identify potential regulatory risks and advise business of upcoming changes in product regulations; assist in countermeasure development and implementation to ensure quick adaption to the new regulations. + Maintain knowledge and understanding of global regulatory requirements with an emphasis on US, EU, and Canada, and provide expertise in translating regulatory requirements into practical and workable plans. + Evaluateregulatoryimpactofproposeddesignandmanufacturingchanges. + Reviewandapprovealllabeling(product,advertisingandpromotional). + Development ofdepartmentalSOPsandimplementation. + Maintainregulatoryfilesasrequiredbydepartmentalprocedure. + AdheretoCodeofEthicsforRegulatoryprofessionals. + Allotherdutiesasrequestedbyhis/hermanager **Knowledge Requirements** + Bachelor’sdegree,preferablyinascientificdisciplinesuchasScience,PharmacyorEngineering. + MastersinRegulatoryAffairsorRegulatoryAffairsCertification(RAC)isaplus. + 5to8yearsofClassIImedicaldeviceregulatoryexperienceisrequired, aesthetic devices is a plus. + Strongregulatorywritingskills. + AbilitytoapplybusinessandRegulatoryAffairsethicalstandards. + Excellentanalyticalandcriticalthinkingskills. _This_ _job_ _description_ _is_ _not_ _all_ _inclusive_ _and_ _is_ _intended_ _to_ _capture_ _a_ _majority_ _of_ _the_ _job_ _functions._ _Special_ _projects_ _and other tasks may be required by management._