Regulatory Affairs Strategist, Globalization (eIFU/ Est. Registrations)
Becton Dickinson NA
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Benefits offered by this job
Job summary
BD in New Jersey is seeking a Regulatory Affairs Strategist, Globalization to align and execute worldwide regulatory strategies and practices across BU, Regional and Central teams. The role requires expertise in labeling, eIFU, establishment registrations, and device listings with a focus on global regulatory excellence.
You will partner with Business Units and Regional Regulatory leaders to drive standardized processes, ensuring flexible, compliant solutions for local needs while maintaining
Qualifications
- Bachelor's degree in science, engineering, or technology required.
- Minimum 8 years of experience in the medical device industry, with at least 5 years in Regulatory Affairs.
- Strong knowledge of labeling, eIFU, establishment registrations, and device listings.
- Global regulatory experience across BU, Regional and Central teams.
Responsibilities
- Provide centralized regulatory governance related global labeling requirements and information management, including eIFU.
- Develop, own and standardize labeling, eIFU, establishment registration and device listing processes.
- Act as a strategic partner to Business Units and Regional Regulatory leaders.
- Coordinate across Business Units, Regions, Central RA, and other functions.
- Harmonize key processes, and build communications channels across RA.
- Assist with risk mitigation plans and solutions.
- Stay apprised of global regulatory policy topics.
Skills
Education
Job description
We are the people who give possibilities purposeBD 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.
- 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, eliminate 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.
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.Experienced in both Business and Regional roles.Regulatory Affairs Certification (RAC).
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 elevate issues as needed, and make key decisions within area of focus. Composure: Responds constructively in stressful situations and elevate issues as needed.. Flexibility: Adapts plans to changing priorities, modeling 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 actionDealing with Ambiguity: Able to assess risk, competing needs and priorities and develop solutions.
(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.
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 BonusPotential 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
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.
At 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.
- 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.
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 displayedOur 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 Range Information $137,500.00 - $220,100.00 USD Annual
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