Job DescriptionThe 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.
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
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$137,500.00 - $220,100.00 USD Annual
