Regulatory Affairs Strategist, Globalization (eIFU/ Est. Registrations)

Becton, Dickinson and Company; Franklin Lakes (NJ); Vor Ort; USD 138.000 - 220.000; Vollzeit

Benefits dieser Stelle

Annual Bonus Potential

Discretionary LTI Bonus

Health and Well-being Benefits

Medical coverage

BD 401(k) Plan

Educational assistance

Paid time off

Zusammenfassung

Becton, Dickinson and Company (BD) is looking for a Regulatory Affairs Strategist, Globalization to shape worldwide regulatory strategies related to labeling, eIFU, registrations and device listings. You will partner with Business Units, Regions and Central RA to drive standardized, scalable processes and compliance excellence.

The role requires strong technical expertise in labeling, eIFU and registrations, plus significant regulatory experience in the medical device sector.

Qualifikationen

• Bachelor's degree in science, engineering, or technology discipline.
• 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) desirable.

Aufgaben

• Provide centralized regulatory governance related global labeling requirements and information management, including eIFU.
• Develop, own and standardize labeling, eIFU, establishment registrations and device listing processes.
• Act as a strategic partner to Business Units and Regional Regulatory leaders for labeling and eIFU programs.
• Coordinate across Business Units, Regions, Central RA, and other functions.
• Harmonize processes and build communications channels across RA teams.
• Assist in risk mitigation planning and solutions.
• Stay apprised of global regulatory policy topics.

Kenntnisse

Regulatory affairs

Labeling

eIFU

Establishment registrations

Device listings

Stakeholder collaboration

Risk mitigation

Regulatory strategy

Regulatory governance

Communication

Ausbildung

Bachelor's degree in science/engineering/technology

Master's degree in business/management/technology

Regulatory Affairs Certification (RAC)

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 Summary:

The Regulatory Affairs Strategist, 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 assigned business practices through tools, processes, and best‑practice sharing. This position requires technical expertise related to labeling, eIFU, establishment registrations, device listings, and the 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 governance related global labeling requirements and information management, indlucing eIFU, ensuring timely insight and clear guidance to Business Units and Regions.
• Help to develop, own and standardize labelign, eIFU, establishment registration and device listing 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 implementation of labeling and eIFU processes and programs.
• Coordinates and networks across Business Units, Regions, Central RA, and other functions.
• Works across business units and regional RA operations teams to harmonize key processes, escalated 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.
• 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.
• Experienced in both Business and Regional roles.
• Regulatory Affairs Certification (RAC).

Knowledge and Skills:

Organization & Planning: 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 provide regulatory assessments and recommendations.

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...

Action Oriented: Demonstrates a significant bias for action to execute key objectives.

Courage & Independence: Able to escalated issues as needed, and make key decisions within area of focus.

Composure: Responds constructively in stressful situations and escalated issues as needed..

Flexibility: Adapts plans to changing priorities, modelling and practicing key principles of change management.

Process Effectiveness: Works to identify ways to simplify and implement complex processes and able to reach out for help where needed.

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.

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%

Benefits:

• 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.

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.

Salary and Compensation:

Salary Range Information $137,500.00 - $220,100.00 USD Annual

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.

Additional Benefits Overview:

Benefits may include: Health & Well-being: Medical, dental, vision, health savings and flexible spending accounts, life and disability insurance, wellness resources, mental health support, and disease management programs. Retirement & Financial Well-being: 401(k), deferred compensation programs, financial counseling, DailyPay, and educational savings resources. Work-Life Balance & Family Support: Paid time off, company holidays, educational assistance, parental leave, adoption assistance, backup care, caregiving support, employee assistance programs, commuter benefits, pet insurance, legal services, and associate discount programs. Leave Programs: Bereavement, military, personal, family and medical leave, and jury duty leave. Additional details regarding benefits and well-being programs can be found in Our Commitment to You.

Work Location and Shift:

Required Skills Optional Skills . Primary Work Location USA NJ - Franklin Lakes Additional Locations Work Shift

Our Motto:

We are the #MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health™. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible.