Job DescriptionJob 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: (Primary Duties, Roles, and/or Authorities)
- 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: (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 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
- Flexible Spending Accounts
- Critical Illness Insurance
- Accidental Injury Insurance
- Short-term disability coverage
- Long-term disability insurance
- Long-term care with life insurance
Other Well-being Resources
- Anxiety management program
- Sleep improvement program
- Diabetes management program
- 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 Deferred Compensation and Restoration Plan
- Baxter Credit Union (BCU)
- College financial aid and application guidance
Life Balance Programs
- Paid time off (PTO), including all required State leaves
- Educational assistance/tuition reimbursement
- Group auto and home insurance
- Discounts on products and services
- Academic Achievement Scholarship
- Service Recognition Awards
- Employer matching donation
Other Life Balance Programs
- Backup day care and eldercare
- Support for neurodivergent adults, children, and caregivers
- Caregiving assistance for elderly and special needs individuals
- Employee Assistance Program (EAP)
- Support for fertility, birthing, postpartum, and age-related hormonal changes
Leave Programs
- Family and Medical Leave (FML)
- Jury and Witness Duty Leave
Required Skills
Optional Skills
Primary Work LocationUSA NJ - Franklin Lakes
Additional LocationsWork ShiftAt 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
