OverviewA key client of EPM Scientific is seeking a Sr. Regulatory Affairs Specialist to join their team on a 12 month contract, supporting primarily around Regulatory Submissions & Intelligence in their Joint Replacement Orthopaedics division. This is a full time role, ASAP start, hybrid on site in Southern Ireland (negotiable).ResponsibilitiesAssesses Regulatory Intelligence to assist in the development regulatory strategiesEvaluates the regulatory environment and provides internal advice throughout the product lifecycleAnticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutionsEvaluates proposed products for regulatory classification and jurisdictionDetermines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activitiesCompares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomesIdentifies the need for new regulatory procedures, SOPs, and participates in development and implementationProvides regulatory input and technical guidance on global regulatory requirements to product development teamsAdvises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations and assesses their acceptabilityProvides regulatory information and guidance for proposed product claims/labelingPrepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelinesMonitors the progress of the regulatory authority review process through appropriate communications with the agencyCommunicates and interacts with regulatory authorities throughout product life cycle and submissionsQualificationsDesired Skills and ExperienceRegulatory Affairs, Orthopedics, 510k, FDA, MDR, Regulatory Submissions, Regulatory Intelligence, Class I, Class IIa, Class IIb, Class III
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