Regulatory Affairs Strategist, Globalization (US/ EU)

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 The Regulatory Affairs Strategist, Globalization, is responsible for implementation of worldwide regulatory affairs strategies and practices related to their assigned area of focus and expertise across the BU, Regional and Central teams. Act as a strategic partner to Business Units and Regional Regulatory leaders, enabling aligned execution of regulatory strategies through tools, processes, and best‑practice sharing.  The role requires a significant understanding of the Regulatory function related to their area of focus and its associated activities. Job Responsibilities: (Primary Duties, Roles, and/or Authorities) Provide centralized regulatory governance related to the registration assessment process.  Able to interpret global regulatory requirements, ensuring timely insight and clear guidance to Business Units and Regions to enable compliant growth and market access. Help to develop and standardize global regulatory registration assessments, driving consistency, efficiency, and scalability across regions while allowing appropriate flexibility to meet local regulatory needs. Act as a partner to Business Units and Regional Regulatory leaders, enabling implementation of global processes related to regulatory registration assessments. Coordinates and networks across Business Units, Regions, Central RA related to the eIPRRA process and helps to identify areas for improvement.  Works across Business Unit and Regional RA operations teams to harmonize key processes, escalate issues, and build communications channels across RA. Works across regulatory affairs teams to identify common pain points and potential solutions. Stays apprised of global regulatory policy topics. Minimum Requirements: Bachelor’s degree in science, engineering, or technology discipline required. Minimum 8 years of experience in the medical device industry, with at least 5 years in Regulatory Affairs. Preferred Qualifications: Master’s degree in business, management, or technology related field preferred. Experienced Business and/or Regional roles. Regulatory Affairs Certification (RAC). Knowledge and Skills: Organization & Planning: Organizes personal and organizational projects and tasks, for assigned projects, enlisting resources to efficiently meet project needs. Problem Solving, Analytical Skills and Professional Judgement: Uses a combination of logic, analysis, and experience to provide regulatory assessments and recommendations. Decision Quality: Developing ability to assess risk and clarify ambiguous situations to make good recommendations. Communication Skills: Able to present problems and recommendations to senior management effectively... Action Oriented: Demonstrates a significant bias for action to execute key objectives.   Courage & Independence: Able to escalate issues as needed and make key recommendations within area of focus. Composure: Responds constructively in stressful situations and escalate issues as needed. Flexibility: Adapts plans to changing priorities. Process Effectiveness: Works to identify ways to simplify and implement complex processes and able to reach out for help where needed. Dealing with Ambiguity: Able to assess risk, competing needs and priorities and develop solutions. 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  Mu