Regulatory Affairs Senior Manager, Digitalization

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 development, etc.) Preferred Qualifications: Master’s degree in business, management, or technology related field Minimum of 5 years in Medical Device industry, with roles in Regulatory Affairs and/or Quality Systems. 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 towards an intended course of action. Experienced at using multiple chains of influence to achieve broad organizational acceptance Dealing with Ambiguity: Anticipates the organizational impact of change, rising to the challenge, applying ingenuity, while accepting risk and uncertainty as normal. Building Effective Teams: Builds mission-driven, cohesive teams of people, sharing team wins and successes throughout the organization to instill team member value and appreciation. Physical Demands: (if applicable) When work is performed in an office environment the position requires the ability to operate standard office equipment and keyboards. Must have the ability to stand, walk and sit; talk or hear, both in person and by telephone; use hands to finger, handle or feel objects or controls; reach with hands and arms. Ability to travel US and OUS travel ~25%. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. At BD, we are committed to supporting our associates’ well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role: Annual Bonus Potential Discretionary LTI Bonus Health and Well-being Benefits Medical coverage Health Savings Accounts Flexible Spending Accounts Dental coverage Vision coverage Hospital Care Insurance Critical Illness Insurance Accidental Injury Insurance Life and AD&D insurance Short-term disability coverage Long-term disability insurance Long-term care with life insurance Other Well-being Resources Anxiety management program Wellness incentives Sleep improvement program Diabetes management program Virtual physical therapy Emotional/mental health support programs Weight management programs Gastrointestinal health program Substance use management program Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit Retirement and Financial Well-being BD 401(k) Plan BD Deferred Compensation and Restoration Plan 529 College Savings Plan Financial counseling Baxter Credit Union (BCU) Daily Pay College financial aid and application guidance Life Balance Programs Paid time off (PTO), including all required State leaves Educational assistance/tuition reimbursement MetLife Legal Plan Group auto and home insurance Pet insurance Commuter benefits Discounts on products and services Academic Achievement Scholarship Service Recognition Awards Employer matching donation Workplace accommodations Other Life Balance Programs Adoption assistance Backup day care and eldercare Support for neurodivergent adults, children, and caregivers Caregiving assistance for elderly and special needs individuals Employee Assistance Program (EAP) Paid Parental Leave Support for fertility, birthing, postpartum, and age-related hormonal changes Leave Programs Bereavement leaves Military leave Personal leave Family and Medical Leave (FML) Jury and Witness Duty Leave Why Join Us? To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success. To learn more about BD visit Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. Required Skills Optional Skills . Primary Work Location USA NJ - Franklin Lakes Additional Locations Work Shift At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You." Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed. Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role. Salary Range Information $172,000.00 - $275,200.00 USD Annual We are the #MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health™. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible. Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.