RA Labeling Compliance & Business Solutions Lead

RA Labeling Compliance and Business Solutions Lead

The RA Labeling Compliance and Business Solutions Lead partners with labeling teams, stakeholder groups, and leadership to assess new challenges and implement solutions. The role reports to BD’s Central Regulatory Affairs team and serves as the Global Process Owner for eIFU, while also supporting BD-wide labeling software initiatives and system improvements.

Job Responsibilities

• Global Process Owner of BD’s eIFU solution; identify data quality/integrity risks, administer policies and procedures, and oversee Power User forums and Change Control Board Meetings.
• Support existing and developing BD X labeling technology platforms, monitor onboarding of BD business units, and participate in system enhancements.
• Continuously develop expertise in labeling regulations and processes to advise on labeling deliverables, initiatives, and challenges.
• Own BD-wide labeling policies and procedures as applicable.
• Regularly review labeling systems and processes to ensure optimization and alignment of regulatory, quality, and business requirements.
• Identify and evaluate new labeling technology solutions, lead projects to ensure implementation success, and support BD Business Units onboarding to BDX labeling platforms.
• Review and assess new/updated regulations impacting BD product labeling; engage stakeholders to incorporate procedural and policy updates.
• Maintain regular communication with labeling stakeholders, monitor activity to identify trends, shared issues, and best practices, and troubleshoot issues collaboratively.
• Assess stakeholder feedback, summarize impacts, identify risks and opportunities, and communicate findings to leadership.
• Escalate when existing processes may not align with new requirements and inspire stakeholders to build solutions.
• Apply business acumen to identify relevant labeling metrics and support regular reporting.
• Report on key project plans, activities performed, and any obstacles.

Leadership Expectations

• Create a sense of energy, excitement, and personal commitment by empowering others, rewarding performance, and fostering an inclusive workplace.
• Advocate for Regulatory Labeling, communicate confidently, distill critical information, and deliver clear messaging.
• Coordinate with peers across BD to communicate and engage them in labeling initiatives, building consensus for process harmonization.
• Build and successfully manage relationships with partner stakeholders.
• Employ logical thought processes and use common sense to reach workable solutions.
• Honor commitments, fulfill obligations, and lead with integrity and professionalism.
• Inspire responsibility for compliance with rules and regulations among peers.

Education And Experience Required

• Bachelor’s degree in a technical, scientific, or related discipline.
• Minimum of ten years overall professional experience.
• Minimum of five years of direct experience in medical device/pharmaceutical labeling, including at least five years with US, EU, and other global medical device regulations.

Knowledge And Skills Required

• Experience working with FDA and/or EU notified bodies.
• Experience in labeling technology deployment (eIFU, content management system, labeling system, or other).
• Experience working in a large, complex, and matrixed organization with proven ability to collaborate and influence cross‑functional teams without formal authority.
• Excellent MS Office Suite skills (Excel, PowerPoint, Word).
• Excellent analytical skills to understand and troubleshoot data quality issues.
• Experience working with relational databases (Excel, Power BI).
• Knowledge of quality system elements (GDP, etc.) and their interactions with ERP systems.

Preferred Qualifications

• Medical Device, IVD, Pharmaceutical experience strongly preferred.

Physical Demands

• Ability to travel approximately 25% US and OUS, or as needed.

Workplace Flexibility

BD typically requires a minimum of four days of in‑office presence per week. Remote or field‑based arrangements may apply to specific roles and will be indicated in the job posting.

Benefits

• Annual Bonus and 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

Salary Range

$132,400.00 – $218,400.00 USD Annual

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.

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