Regulatory Affairs Senior Director, Digitalization

Job description

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 DescriptionThe Senior Director of Regulatory Affairs, Digitalization, reports to the Vice President of Regulatory Affairs, Regulatory Affairs Management, Enterprise Excellence, and 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. This role is accountable for shaping and driving 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 Advertising and Promotion, Regulatory Documentation and Submission Management, and Regulatory Information Management. The Senior Director of Regulatory Affairs, Digitalization may serve and/or lead as a member of applicable BDX Steering Committees, and 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). Leads BU digital center of excellence. Incubator for artificial intelligence (AI) ideas and execution. Through exceptional communication, cross-functional collaboration, and agile problem-solving, the Senior Director partners with 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: Manage Global RA Digital Platforms: Establish and lead a team to implement, manage, maintain and improve Regulatory Affairs digital platforms, such as regulatory and product information management, submission management, and advertising and promotion. 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. Lead 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. Lead 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. Manage the Digital RA Portfolio: Oversee the prioritization and execution of digital regulatory initiatives, ensuring timely delivery, measurable outcomes, and stakeholder alignment. Orchestrate Cross-Functional Partnerships: Partner with TGS, ISC, and Business Unit teams to co-create and implement initiatives and digital solutions from concept through deployment. 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. 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. Centralize and elevate BD RA analytics and reporting capabilities: Develop a unified data strategy that enables holistic, predictive, and AI-driven insights. Drive operational efficiency, accelerate decision-making, and proactively identify quality trends and opportunities for continuous improvement across the enterprise. Act as deputy for the VP, Central Regulatory, providing strategic support and leadership continuity. 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 Digital Globalization Regulatory Affairs team. Direct the preparation of the department budgets and maintain operating costs within constraints of those budgets. Manages project budgets and IT budgets as needed. Education and Experience: Bachelor’s degree in science, engineering, or technology discipline required. Master’s degree in business, management, or technology related field preferred. Minimum of 5 years in Medical Device industry, with roles in Regulatory Affairs and/or Quality Systems preferred. Minimum 15 years working with IT to launch and maintain RA Systems following GxP, Computer Systems Validation (CSV) and Software Development Lifecycle (SDLC) standards Minimum 15 years of experience in business operations management (budget/resource planning, technology management, business case development, talent development, etc.) Knowledge and Skills: Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of multiple simultaneous projects, enlisting resources to efficiently meet project needs. Problem Solving, Analytical Skills and Professional Judgement: Uses a combination of logic, analysis, experience, wisdom, and advanced methods to make decisions and solve problems, demonstrating the ability to solve difficult problems and create effective and innovative solutions. Decision Quality: Accurately assesses risk and clarifies ambiguous situations to make good decisions, developing alternatives with clearly documented consequences for each possible course of action. Communication Skills: Skilled facilitator for small and large groups and organizations, adapting content and style to engage audience, and able to articulately respond to impromptu comments and questions. Action Oriented: Demonstrates a significant bias for action to execute key objectives, while actively seeking other opportunities to contribute. Courage & Independence: Seeks out and selects stimulating work with challenges, increasing scope and responsibilities. Composure: Responds constructively in stressful situations and effectively calms others while taking action to resolve the root cause of the situation causing stress. Flexibility: Adapts plans to changing priorities, modeling and practicing key principles of change management. Process Effectiveness: Independently identifies the most efficient way to simplify and implement complex processes. Process and Service Acumen: Thorough understanding of service-related processes and service engineering with ability to independently influence organizational direction. Organizational Agility: Is cognizant of organizational culture in a matrixed environment and appropriately adjusts personal style to be effective. Builds numerous and beneficial relationships through personal networks, inside and outside the organization. Influencing Others: Leverages internal or external experts or third parties to influence others