Regulatory Affairs & Commercial Quality Excellence Manager
Core
Lead regulatory operations and commercial quality excellence activities across the Emerging Markets region to drive compliance, operational excellence, and business growth.
Role type
Senior Regulatory Affairs & Quality Excellence Manager
Builds
Regulatory submission strategies, quality management systems, and cross-functional process improvements for medical devices in Emerging Markets.
Domain
Medical Devices / Regulatory Affairs / Quality Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission management, Quality Management System (QMS) development, Lean/Six Sigma methodologies, auditing, SOP authoring, cross-functional leadership, stakeholder management, supply chain quality oversight, distributor business model support.
Preferred skills
Experience with regulatory systems and databases, gap assessment techniques, talent development, succession planning.
Technologies
Regulatory databases, QMS software, Lean/Six Sigma tools
Responsibilities
Develop and implement regulatory operational strategies; lead regulatory submission activities; champion continuous improvement and inspection readiness; monitor QMS performance; provide leadership and coaching to regional teams; support system audits and regulatory inspections.
Seniority
Senior, hands-on IC with leadership responsibilities
