Regulatory Affairs Senior Manager, Digitalization

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We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description Job Summary: The Senior Manager of Regulatory Affairs, Digitalization is responsible for establishing, executing, and maintaining the central regulatory affairs strategy for digital tools and systems required for regulatory activities and work across BUs and Regions, specifically the Regulatory Information Management System (RIM and/or RIMSYS). This role is accountable for supporting a comprehensive digital regulatory roadmap and portfolio that accelerates innovation, enhances operational excellence, and enables data-driven decision-making across business units and regions. The role has responsibilities for the management, maintenance, and improvements of digital platforms operated and utilized by Regulatory Affairs, including systems related to Regulatory Documentation and Submission Management, and Regulatory Information Management. The Senior Manager of Regulatory Affairs, Digitalization will work with SMEs and stakeholders from Central, BU and Regional teams to ensure user needs are identified and met. Coordinates with cross-functional teams and departments to incorporate global regulatory strategy into GPDS (digital solution). Supports BU digital center of excellence. Through exceptional communication, cross-functional collaboration, and agile problem-solving, the Senior Manager partners with the Senior RA Director, Digitalization, and senior leadership to refine the Regulatory Affairs vision, identify transformative opportunities, and lead high-impact initiatives that elevate BD's quality standards and customer trust. Job Responsibilities: (Primary Duties, Roles, and/or Authorities) Primary Responsibilities : Support Global RA Digital Platforms : Improve the Regulatory Affairs digital platform of regulatory and product information management and submission management. Help Shape the Global RA Strategy : Partner with senior leadership to define and evolve BD's RA digital strategy, recommending strategic opportunities and initiatives that drive global impact. Support Strategic Initiative Development : Identify, prioritize, and formalize global RA programs in partnership with the Senior Regulatory Leadership team, by analyzing internal performance data, external benchmarks, emerging digital, technical, and assessing impact, value and alignment with Global Regulatory Strategy. Support the Digital RA Roadmap : Define and drive BD's Digital RA strategy, ensuring alignment with enterprise priorities and integration across Segments, Business Units, and Regions. Support the Digital RA Portfolio : Oversee the prioritization and execution of digital regulatory initiatives, ensuring timely delivery, measurable outcomes, and stakeholder alignment. Form Cross-Functional Partnerships : Partner with TGS, ISC, and Business Unit teams to co-create and implement initiatives and digital solutions from concept through deployment. Help Define and Align Key Driver Goals : Co-create regulatory function goals with the Regulatory Leadership Team and lead, where applicable, initiatives to achieve measurable outcomes across global teams. Support RA System Optimization : Collaborate central teams, business units and regional partners to implement a flexible, efficient, and scalable technology. Leverage digital tools and automation to enhance system flexibility, operational efficiency, and global harmonization. SDLC (Software Development Life Cycle) Support Leads the application test planning and execution (PQ/Use Acceptance Testing) Reviews SDLC documents and participate in key workshops; ensure user requirements, business process and design are understood / aligned Act as business test lead and develop and execute test scripts Assists in regression testing for periodic/infrastructure upgrades Provides CSV/Validation centric input on enhancement requests Supervision and Budgetary Responsibility : Manage the RIMSYS team. Direct the preparation of the RIM and RIMSYS budgets and maintain operating costs within constraints of those budgets. Manages project budgets and IT budgets as needed. Minimum Requirements: Bachelor's degree in science, engineering, or technology discipline required. Minimum of 5 years in Medical Device industry. Minimum 5 years working with IT to launch and maintain RA Systems following GxP, Computer Systems Validation (CSV) and Software Development Lifecycle (SDLC) standards Minimum 10 years of experience in business operations management (budget/resource planning, technology management, business case development, talent developme