Sr Manager, Regulatory Operations - Publishing & Registration Management (Devices)
Core
Direct product/process submissions for medical devices to ensure timely global regulatory approvals and maintain compliance.
Role type
Senior Manager, Regulatory Operations (Management Path)
Builds
Regulatory dossiers, submission documents, and licensing for medical devices
Domain
Medical Devices / Regulatory Affairs
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 (US/EU/Canada), FDA eSTAR, Health Canada REP, EU Notified Body portals, CDRH CECATS, export certification (CFG/COE/FSC), apostille/legalization processes, market access strategy, process improvement
Technologies
FDA eSTAR, Health Canada REP, EU Notified Body portals, CDRH CECATS
Responsibilities
Oversee multiple regulatory operations projects; lead teams on dossier preparation and submission management; make key decisions impacting project performance; adhere to GxP regulations and SOPs; optimize documentation processes for international submissions
Seniority
Senior, hands-on IC with leadership responsibilities