Regulatory Affairs Strategist, Globalization (US/ EU)

BD; Franklin Lakes (NJ); Vor Ort; USD 137.500 - 220.100; Vollzeit

Benefits dieser Stelle

Annual Bonus

Discretionary LTI Bonus

Medical coverage

Health Savings Accounts

Dental coverage

Vision coverage

Zusammenfassung

BD is seeking a Regulatory Affairs Strategist, Globalization, to lead worldwide regulatory strategies for assigned areas. You will partner with Business Units and Regional leaders to enable compliant growth and market access through standardized processes.

The role requires a strong RA background with 8+ years in medical devices and 5+ years in regulatory affairs; RAC and a Master’s degree are a plus. On‑site collaboration is emphasized.

Qualifikationen

• 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.
• Master’s degree in business, management, or technology related field preferred.
• Regulatory Affairs Certification (RAC) preferred.

Aufgaben

• Provide centralized regulatory governance related to the registration assessment process.
• Interpret global regulatory requirements to enable compliant growth and market access.
• Develop and standardize global regulatory registration assessments for cross‑regional use.
• Coordinate across Business Units, Regions, Central RA on eIPRRA processes.
• Harmonize key RA processes and build cross‑functional communication channels.
• Stay apprised of global regulatory policy topics.

Kenntnisse

Regulatory affairs

Strategic partnering

Regulatory policy

Communication

Cross-functional collaboration

Ausbildung

Bachelor’s degree in science/engineering/tech

Master’s degree preferred

Tools

eIPRRA

RA processes

Jobbeschreibung

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

• 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, escalated 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 escalating issues as needed and make key recommendations within area of focus.
• Composure: Responds constructively in stressful situations and elevate 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

• 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.

Benefits

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
• Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit

Retirement and Financial Well‑being

• BD 401(k) Plan
• BD Deferred Compensation and Restoration Plan
• 529 College Savings Plan
• Financial counseling
• 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
• Support for fertility, birthing, postpartum, and age‑related hormonal changes

Leave Programs

• Bereavement leaves
• Military leave
• Personal leave
• Family and Medical Leave (FML)
• Jury and Witness Duty Leave

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.

Required Skills

Optional Skills

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

Salary Range Information

$137,500.00 - $220,100.00 USD Annual