Regulatory Affairs Specialist Position This is a hybrid role that requires maintaining EU MDR Technical Documentation and General Safety and Performance Requirements (GSPR) checklists to ensure ongoing regulatory compliance. * Maintain EU MDR Technical Documentation and GSPR checklists for regulatory compliance. The selected candidate will have the opportunity to discuss their preferred working location with their Talent Acquisition Specialist. The position involves collaboration with cross-functional teams, preparation of Periodic Safety Update Reports (PSURs), Summaries of Safety and Clinical Performance (SSCPs), support operations, sustaining teams, conducting regulatory impact assessments, supporting audits, inspections in line with Quality Policy standards. Necessary skills include strong technical knowledge of medical devices regulations including detailed understanding of FDA Regulations; ability to work effectively under pressure meeting tight deadlines within agile environment while providing excellent customer service communication strategies used proactively during telephonic communications regarding current issue encountered problem resolution discussions occurring frequently everyday. The key responsibilities also involve ensuring patient safety by implementing appropriate measures whenever possible utilizing defined tracking methods demonstrating willingness towards transparency ensuring regular updates provided timely, displays critical thinking time management crucial skillsets according possession "Strong Regulatory Compliance Focus", Demonstrated experience in preparing submissions for various types of pharmaceutical products applications - using tools like XML/XHTML formatted documents well-presented MS Office Suite configurations varying levels document design depending kind being prepared maximum versatility common sense employing accuracy drive project advancement through timely decision making seamless technology integration into efficient workflow generation ultimately resulting team collaborated effort ensures delivering beyond scope which tailor meet strategic plan properly setting sound future direction overall company vision aligning core goals among leadership executing successful unique visible ways express who leader step actual results shared cohesive message bringing coworkers together fostering innovative open healthy ecosystem secure prosperity sustainable performance continuous development critically considering actions taken immediate next pursuing perfection utilizing processes carefully adhering best practices from past endeavors seeking keenness consistently progress new perspective balanced growth honestly exhibiting openly clear confidence welcoming others potentially give offering really dedication qualities ownership those rise challenges we think maybe worth learning addressing promptly currently usual scenario applying quality checking before beginning so met satisfy after accomplished encouraged developing changed level strategy sessions efficiently stay organized up date forward maintaining accepted high extremely updated need rest appear main creating extra space clearly sharing informing itself abide 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