Senior Regulatory SpecialistWe are seeking a Senior Regulatory Specialist to join one of our leading healthcare clients.Position OverviewSeeking a Senior Regulatory Affairs Specialist to support global regulatory operations, international tenders, and regulatory documentation activities. This role requires strong project management, cross-functional leadership, and regulatory compliance experience.Top Skills RequiredGlobal Tender & Project ManagementCross-Functional LeadershipRegulatory Operations & Global Compliance (MDR, International Submissions)Key ResponsibilitiesLead end-to-end regulatory support for international tenders.Coordinate regulatory documentation, certifications, and compliance requirements.Manage project timelines, trackers, and deliverables to ensure on-time execution.Review and process regulatory documents, including LoA, PoA, CFGs, COEs, and Declarations of Conformity (DoC).Ensure compliance with EU MDR, international regulations, and Good Documentation Practices (GDP).Collaborate with Regulatory Affairs, Quality, Supply Chain, Legal, R&D, and international affiliates.Support process improvements, CAPA activities, and regulatory compliance initiatives.Required QualificationsExperience in Regulatory Affairs, Regulatory Operations, or Global Regulatory Submissions.Strong project management and stakeholder management skills.Knowledge of EU MDR and international regulatory requirements.Excellent communication, organizational, and problem-solving abilities.Ability to manage multiple projects independently in a fast-paced environment.Preferred SkillsGlobal Regulatory SubmissionsTender ManagementEU MDRCAPAGood Documentation Practices (GDP)SharePointProcess Improvement