Regulatory Affairs Strategist, Globalization (US/ EU)

About the role

The Regulatory Affairs Strategist, Globalization is responsible for implementing worldwide regulatory affairs strategies and practices related to their assigned area of focus and expertise across Business Units, Regional, and Central teams. This role acts as a strategic partner to Business Units and Regional Regulatory leaders, enabling aligned execution of regulatory strategies through tools, processes, and best-practice sharing.

Responsibilities

• 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.
• Covers coordination and networking 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.

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).

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.

Benefits

• Annual Bonus
• Potential Discretionary LTI Bonus
• Health and Well-being Benefits
• Health coverage
• 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
• BD 401(k) Plan
• 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
• Leave Programs
• Bereavement leaves
• Military leave
• Personal leave
• Family and Medical Leave (FML)
• Jury and Witness Duty Leave