Regulatory Affairs Manager page is loadedRegulatory Affairs ManagerApply locations Cork, Ireland time type Full time posted on Posted Yesterday job requisition id R543519 Work Flexibility: OnsiteRegulatory Affairs Manager- candidate can come from Quality or Regulatory background.This is a permanent role with full Stryker benefits- bonus, pension and healthcare for employee and their family.Key Areas of Responsibility:Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategyDevelops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategiesProvides guidance to integrate regulatory considerations into global product entry and exit strategyIdentifies regulatory pathways for initial product designs and provides input to internal stakeholdersAnalyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomesAssesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstaclesCritically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulationsProvides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy)Negotiates with regulatory authorities on complex issues throughout the product lifecycleEstablishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distributionIdentifies the need for and manages the development and execution of new regulatory procedures and standard operating proceduresDevelops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide complianceProvides strategic input and technical guidance on global regulatory requirements to product development termsEvaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutionsEvaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissionsReviews and assesses proposals to regulatory authorities on regulatory paths and clinical plansMonitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phasesProvides knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationshipsProvides regulatory guidance on strategy for proposed product claims/labelingEnsures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claimsEnsures policies and procedures are in place for appropriate internal review and approval of regulatory submissionsLeads key negotiations and interactions with regulatory authorities during all stages of the development and review processPrepares cross-functional teams for interactions with regulatory authorities including panel/advisory committeesEducation / Work Experience:BS in a science, engineering or related Advanced degree preferredMinimum of 8 years experiencePeople Management experience required#IJ#INDEMEATravel Percentage: 20%Similar Jobs (2)Senior Regulatory Affairs Specialistlocations Cork, Ireland time type Full time posted on Posted 8 Days AgoStaff Specialist, Regulatory Affairslocations Cork, Ireland time type Full time posted on Posted 2 Days Ago
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