Associate Specialist, Regulatory Affairs Operations TMTT
Core
Develop regulatory process improvements, coordinate submission deliverables, and prepare documentation packages for global regulatory agencies to ensure medical device compliance.
Role type
Associate Specialist, Regulatory Affairs Operations
Builds
Regulatory submission documentation and process enhancements for Transcatheter Mitral and Tricuspid Therapies (TMTT) devices.
Domain
Medical Devices / Regulatory Affairs
Required skills
Regulatory submission coordination, documentation compilation, regulatory record management, system maintenance, compliance interpretation, audit preparation
Preferred skills
Project management leadership, Microsoft Office Suite proficiency, global medical device regulations knowledge, new product regulatory requirements knowledge
Technologies
Microsoft Office Suite, regulatory databases, tracking tools
Responsibilities
Develop routine Regulatory Affairs process improvement initiatives including system enhancements and dashboards; Execute coordination of submissions deliverables, schedule and tracking of appendices and documents; Prepare compilation and publication of paper and electronic documentation packages for submission to global regulatory agencies; Support management, retrieval, archival, and maintenance of regulatory records; Maintain regulatory systems, databases, and tracking tools; Review and/or interpret standard assessments to ensure product compliance; Prepare for regulatory agency inspections and audits
Seniority
Associate, hands-on IC