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The Regulatory Affairs Program Manager will play a critical role within Philips Patient Safety & Quality Organization, responsible for enhancing tracking and controlling systems to optimize regulatory compliance monitoring and reporting efficiency, implementing robust systems and processes to ensure accurate and timely compliance of global Unique Device Identification (UDI) requirements. Your role: Serves as a key liaison with external/internal stakeholders to maintain enterprise compliance globally for UDI. Comprehensive evaluations of the organization to assess its current level of regulatory excellence maturity, identifying strengths, weaknesses, and opportunities for improvement. Leads strategic initiatives towards enhanced performance to further improve regulatory compliance efforts and reviews the creation or modification of operational infrastructures to support strategic objectives and drive sustainable results. Leads programs/projects focused on regulatory compliance with UDI requirements, Computer System Validation (CSV) and process improvement by applying/utilizing lean tools- 6S, Kaizen, and continuous improvement methodologies to enhance performance, address regulatory challenges, problem solving techniques, management practices and drive organizational change. Responsible for comprehensive evaluations of the organization to assess its current level of Regulatory Excellence maturity, identifying strengths, weaknesses, and opportunities for improvement, thereby guiding strategic initiatives towards enhanced performance. Enhances tracking and control systems to optimize regulatory compliance monitoring and reporting efficiency, implementing robust systems and processes to ensure accurate and timely tracking of regulatory activities and ensures validation of regulatory affairs software tools.
