Senior Regulatory Affairs Specialist

Senior Regulatory Affairs SpecialistWe are seeking a Senior Regulatory Affairs Specialist to join one of our leading healthcare clients.Position Overview:Submission Readiness & Execution. Provide Regulatory Affairs support for multiple global submissions by coordinating submission readiness activities, tracking Regulatory Affairs deliverables, supporting compilation of submission documentation, and helping ensure key regulatory milestones are achieved. This role partners closely with Regulatory Affairs leads and project teams to maintain visibility to commitments, proactively identify risks, and support timely submission execution.Top Skills and Experience:Deliverable & Timeline Management, Regulatory Submission Coordination, Cross-Functional CoordinationResponsibilities Include:Maintain Regulatory Affairs deliverable trackers and monitor progress against established submission timelines.Conduct routine reviews of regulatory deliverables, action items, and dependencies to support submission readiness.Work closely with Regulatory Affairs leads to identify, communicate, and help address risks to planned regulatory milestones and submission dates.Collaborate with project management and cross-functional teams to ensure Regulatory Affairs activities and milestones are accurately reflected in project schedules and planning tools.Support preparation of regulatory status updates, milestone reviews, dashboards, and management communications.Coordinate Regulatory Affairs meetings supporting submission planning, review activities, and issue resolution.Assist with compilation, organization, and maintenance of regulatory documentation in accordance with established procedures.Support preliminary regulatory assessments and coordination activities associated with product, manufacturing, or labeling changes under direction of Regulatory Affairs personnel.Years/Experience:Minimum 2+ years of regulatory affairs experience or related medical device experienceExperience supporting global regulatory submissions and registration activitiesExperience working within complex, cross-functional product development environmentsExperience utilizing project planning tools, milestone trackers, and Gantt schedules preferredExperience supporting multiple concurrent projects and managing competing prioritiesSkills:Working knowledge of medical device regulatory processes and submissionsStrong organizational, communication, and follow-up skillsAbility to monitor and track complex deliverables across multiple stakeholdersExperience supporting preparation and review of regulatory submission documentationStrong attention to detail and problem-solving skillsAbility to proactively identify risks, gaps, and timing concerns impacting regulatory deliverablesExperience preparing status updates and management reportsProficiency in Microsoft Office applications, including Excel and PowerPointExperience with project planning and tracking tools preferredEducation:Bachelor's Degree in a scientific, engineering, regulatory affairs, business, or related discipline required