Regulatory Affairs Specialist
Core
Supports regulatory strategy, maintains registrations and listings, and ensures compliance with global regulatory bodies for sterilization and lab testing services.
Role type
Regulatory Affairs Specialist
Builds
Regulatory compliance and registration status for medical device, pharmaceutical, and food safety clients
Domain
Healthcare / Medical Device / Pharmaceuticals / Food Safety
Deliverable
client delivery
Required skills
FDA regulations knowledge, ISO 13485 knowledge, GDUFA requirements management, FSMA compliance, registration and listing system management, CAPA experience, document control
Preferred skills
PCQI/FDQI certification, FSMA requirements knowledge, FURLS/CDERDirect system familiarity
Technologies
FURLS, CDERDirect
Responsibilities
Maintain registration and listings for sterilization sites, manage FDA annual updates and GDUFA requirements, respond to customer service inquiries regarding FDA registration, provide training on registration processes, deliver facility reports for inspections, assist with Food Safety and Food Defense plan changes
Seniority
Mid-level, hands-on IC