Overview

Job Summary Responsible for leading and managing the Global Process, Systems & Center of Excellence team supporting postmarket processes including but not limited to complaint management, investigations, failure analysis, device vigilance, regulatory reporting and pharmacovigilance processes to assure regulatory compliance, process standardization, and consistent implementation throughout the organization and across all Medline's product portfolios. Provide management oversight for the development, ownership, maintenance, harmonization, and implementation of global postmarket processes, procedures, work instructions, reportability frameworks, coding standards, and associated governance. Provide management oversight for global complaint/AE IT system governance, including business and user requirements, fields, workflows, codes, lists of values, business rules, data standards, integrations, configuration requirements, and system change management. Provides management oversight of the Global Process, Systems & Center of Excellence team and lead global governance, best practices, process standardization, training support, inspection readiness, compliance oversight, global harmonization, acquisition integrations and continuous improvement. Job Description MAJOR RESPONSIBILITIES: Manage Medline's development, governance, implementation, and continuous improvement of global postmarket surveillance including complaint management, investigation, device vigilance, regulatory reporting and pharmacovigilance processes and strategies. Identify, lead, and drive opportunities to improve global process effectiveness, compliance, standardization, and harmonization. Lead the Center of Excellence for processes, systems, and standards, including best practices, global process standardization, global harmonization, process and procedures, device vigilance reportability framework, coding standards and governance, training program, process compliance, and continuous improvement. Manage Global Process, Systems & Center of Excellence personnel responsible for the development, ownership, maintenance, and harmonization of global procedures, work instructions, process requirements, reportability frameworks, coding standards, and associated controlled documentation. Manage complaint/AE IT system governance, including user and business requirements, fields, workflows, codes, lists of values, business rules, integrations, configuration requirements, system enhancements, and change management. Work with global and cross-functional partners to ensure adequate implementation, integration of acquisitions, governance, and continuous improvement of Medline's processes and systems to meet global needs and changing regulatory requirements. Lead development and maintenance of governance mechanisms, including operational reviews, management reviews, process performance monitoring, compliance oversight, and escalation of identified process, system, or data issues. Lead cross-functional integration management of processes and systems, partnering with Quality, Regulatory Affairs, Medical/Clinical, Product Divisions, Operations, IT, and other applicable functions to ensure requirements and process interfaces are appropriately defined and maintained. Stay current with applicable regulatory requirements and standards and assess changes to determine potential impact to global procedures, work instructions, frameworks, standards, and governance processes, to maintain alignment with applicable requirements and current practices. Provide global support for FDA, Notified Body, MDSAP, and other applicable regulatory inspections and audits. Lead and support inspection readiness and process compliance activities, including assessment of process and system controls, identification of compliance opportunities, support of corrective actions, and evaluation of the effectiveness of implemented improvements. Manage global implementation activities associated with new or revised processe