Sr Manager, Regulatory Operations - Publishing & Registration Management (Devices)
Core
Direct product/process submissions and manage global strategies to ensure medical device compliance and timely approvals.
Role type
Senior Manager, Regulatory Operations (Management Path)
Builds
Regulatory dossiers, submission documents, and licensing for medical devices
Domain
Medical Devices / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission lifecycle management, dossier preparation, submission publishing, licensing, labeling, project management, problem-solving, leadership, GxP compliance, documentation control
Preferred skills
Expertise in Class I/II/III device submissions, knowledge of FDA eSTAR, Health Canada REP, EU Notified Body portals, export certification (CECATS), apostille/notarization/legalization processes, global market access strategy, process improvement
Technologies
FDA eSTAR, Health Canada REP, EU Notified Body portals, CECATS
Responsibilities
Oversee multiple regulatory operations projects for medical devices; Lead teams responsible for dossier preparation, clinical trial disclosure, and submission management; Make key decisions impacting project performance; Apply project management and leadership to ensure GxP compliance; Identify and implement process improvements to reduce submission cycle times
Seniority
Senior Manager, hands-on leadership