Senior Regulatory Labeling Specialist
Core
Ensure regulatory compliance for product labeling across devices, drugs, cosmetics, and supplements by reviewing submissions, researching regulations, and managing compliance gaps.
Role type
Senior Regulatory Labeling Specialist
Builds
Regulatory-compliant packaging and collateral for medical devices, pharmaceuticals, and consumer health products
Domain
Healthcare / Life Sciences / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory compliance evaluation, FDA product codes knowledge, Quality Management Systems, Good Manufacturing Practices, risk-based approach, internal auditing, CAPA process ownership, process improvement (Kaizen), database management, training and mentoring
Preferred skills
Regulatory risk evaluation, advanced project management, complex information evaluation for standards compliance
Technologies
MS Office Suite (Word, Excel, PowerPoint, Outlook)
Responsibilities
Review and verify packaging submissions for label content compliance; Research regulatory changes for assigned products; Lead cross-functional process improvement initiatives; Conduct internal audits and maintain department databases; Address compliance gaps through CAPA processes; Train and mentor employees on regulatory procedures
Seniority
Senior, hands-on IC with mentorship responsibilities
