Senior RA Specialist, CEOT (EU MDR)Location: Cork, Ireland
Employment Type: Full-time
Posted on: Posted Yesterday
Job Requisition ID: R523728
Work Flexibility: Hybrid or Onsite
Permanent Hybrid role based in Carrigtwohill, Cork What you will do: Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategiesEvaluate the regulatory environment and contribute to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product complianceAnticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutionsIdentify requirements and potential obstacles for market access distribution (federal, provincial/territorial, state, reimbursement, purchasing groups, etc.)Assist in the development of regulatory strategy and update strategy based upon regulatory changesEvaluate proposed products for regulatory classification and jurisdictionDetermine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activitiesProvide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organizationCompare regulatory outcomes with initial product concepts and recommend changes or refinements based on initial regulatory outcomesNegotiate with regulatory authorities throughout the product lifecycleIdentify the need for new regulatory procedures, SOPs, and participate in development and implementationHelp train stakeholders on current and new regulatory requirements to ensure organization-wide complianceAssist other departments in the development of SOPs to ensure regulatory complianceProvide regulatory input and technical guidance on global regulatory requirements to product development teamsAdvise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulationsAssess the acceptability of quality, preclinical, and clinical documents for submission filing to comply with applicable regulationsEvaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans/strategize (if appropriate) for changes that do not require submissionsWhat you will need: BS in Engineering, Science, or related degree; or MS in Regulatory ScienceTypically a minimum of 2 years' experienceMS or RAC(s) preferredTravel Percentage: None
#J-18808-Ljbffr
