Job Summary:
The Regulatory Affairs Sr. Manager, Globalization is responsible for alignment and execution of worldwide regulatory affairs strategies and practices related to their assigned area of focus and expertise across 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. This position requires technical expertise related to product information management, and ability to leverage global experience, standards, and intel. The role requires a significant understanding of the Regulatory function related to their area of focus and its associated activities.
Job Responsibilities:
- Provide centralized regulatory intelligence and governance related to global product information management, ensuring timely insight and clear guidance to Business Units and Regions.
- Own and standardize product information processes, driving consistency, efficiency, and scalability across business units and regions while allowing appropriate flexibility to meet local regulatory needs.
- 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.
- Coordinates and networks across Business Units, Regions, Central RA, and other functions to influence, manage, and/or oversee product information programs and identify areas for improvement.
- Trains, develops, and manages a highly effective regulatory team through direct and indirect reporting structures. Works across business units and regional RA operations teams to harmonize key processes, escalate issues, and build communications channels across RA.
- Aids business units and functional groups in the creation of risk mitigation plans and solutions.
- Works across regulatory affairs teams to identify common pain points and potential solutions.
- Drive BD’s global regulatory strategy and vision, in collaboration with regional leads, business leads, functional stakeholders.
- Stays apprised of global regulatory policy topics.
Minimum Requirements:
- Bachelor’s degree in science, engineering, or technology discipline required.
- Minimum 10 years of experience in the medical device industry, with at least 8 years in Regulatory Affairs.
Preferred Qualifications:
- Master’s degree in business, management, or technology related field.
- Experienced in both Business and Regional roles.
- Regulatory Affairs Certification (RAC).
Knowledge and Skills:
- Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of assigned 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 thorough regulatory assessments demonstrating the ability to solve difficult problems.
- Decision Quality: Accurately assesses risk and clarifies ambiguous situations to make good decisions, developing alternatives based on risk assessment.
- Communication Skills: Able to present problems and recommendations to senior management effectively and accurately. Able to act as facilitator for small and large groups, and able to work with a diverse group of colleagues..
- Action Oriented: Demonstrates a significant bias for action to execute key objectives, while actively seeking other opportunities to contribute.
- Courage & Independence: Able to escalate issues as needed, and make key decisions within area of focus.
- Composure: Responds constructively in stressful situations and able to drive to root cause of potential issues..
- Flexibility: Adapts plans to changing priorities.
- Process Effectiveness: Independently identifies the efficient ways to simplify and implement complex processes and able to reach out for help where needed.
- 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
- Dealing with Ambiguity: Able to assess risk, competing needs and priorities and develop solutions.
- 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:
- 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%
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 https://bd.com/careers.
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.
