Sr Regulatory Operation Specialist
Core
Manage international regulatory registrations, licensing, and product change notices for medical devices across USA, Canada, and EU regions.
Role type
Senior Regulatory Operations Specialist
Builds
Submission packages, registration dossiers, and compliance dashboards for global markets
Domain
Medical Devices / Regulatory Affairs
Required skills
International registration management, Regulatory Information Management (RIM) database administration, Submission package creation, Product Change Notice (PCN) initiation, Label change request monitoring, Dashboard maintenance, Documentation management, Data analysis, Office 365/Power BI, Quality management systems
Preferred skills
RAPS RAC certification, Quality management system experience, Product development procedures, Regulatory intelligence, Process improvement
Technologies
RIMSYS, ReedTech, EUDAMED, GUDID, Power BI, Office 365
Responsibilities
Upload and validate regulatory data into RIM database, Create submission packages for international registrations, Initiate renewals and product change notices, Monitor label change requests and ensure timely release, Maintain regulatory databases (EUDAMED, GUDID), Establish registrations and device listings for USA, Canada, and EU, Maintain repository of conformity declarations and 510(k)s, Develop and maintain reporting dashboards for gap assessments
Seniority
Senior, hands-on IC