Managing and executing Regulatory Information Management System (RIMS) implementation engagements for Medical Device customers,
including analysis of existing client business processes and systems; definition and documentation of specific business requirements; RIM
solution design and configuration; user training; and deployment support.

Essential Functions

Provide best practices for use of RIM systems and RIM configuration
• Lead gathering and analysis of regulatory business processes and requirements
• Lead RIM system design and configuration sessions with the clients
• Lead gathering of requirements for registrations, submissions, and data migrations
• Accountability of document deliverables (requirement and specification documents, workshops, CRPs, Business test scenarios, IQ, OQ,
PQ)
• Design, build and implement system configuration for clients
• Conduct POCs to understand the effectiveness of the solution when required, and incorporate feedback into the solution
• Closely work with clients and vendors to support implementation and resolve product issues
• Prepare for, facilitate, and lead client meetings and workshops
• Lead project workstreams, planning and tracking of workstream tasks, risks, issues and provide status reporting
• Implement quality measures to drive operational efficiencies and articulate the value to the customer
• Provide application validation expertise on RIM systems products
• Development, execution, approval, and monitoring of the qualification deliverables for GAMP Software categories (IQ, OQ, PQ scripts and
protocols, results, and reports)
• Manage client interface, and ensure project team achieves efficient and effective project delivery

Qualifications

• Strong domain knowledge within medical device regulatory information management, regulatory operations, and/or regulatory intelligence
• Knowledge of regulations for Medical Devices (21 CFR 820 & EU MDR), Quality Management System (ISO 13485), as well as related
technical standards applicable to medical devices and software used for Medical Devices (IEC 62304)
• Knowledge of the relevant national and international legislation, procedural regulations and technical regulations related to product
registrations and submissions
• Experience with implementation of RIM systems based on best practices in the medical device industry
• Experience leading requirements gathering sessions, and working with business teams to gather and write requirements for RIM solutions
• Experience with formal system testing practices/validation.
• Excellent communication and inter-personal skills
• Experience in building and mentoring result-oriented consultant delivery
• Hands-on functional experience on any RIM solutions, including registration and submission management systems
• Available to travel to client sites
• Readiness to work hours that overlap with global client location time-zones
• Experience creating project deliverables following good document practices

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com