RA Labeling Compliance Lead

Role Overview

• Global Process Owner of BD’s eIFU solution; helps identify data quality/integrity risks and resolve/escalate as appropriate, administers, and ensures functional policies and procedures are followed, and oversees Power User forums and Change Control Board Meetings.
• Support of existing and developing BDX labeling technology platforms, including monitoring the onboarding of BD businesses to those solutions and participating in identifying/implementing/validating system enhancements.
• Continuous development of expertise in labeling regulations and processes across BD to provide both advisement and support of labeling deliverables, initiatives, and challenges.
• Owns BD-wide labeling policies and procedures, as applicable.
• Regular review of Labeling systems and processes to ensure optimization and alignment of regulatory, quality, and business requirements.
• Identification/evaluation of new labeling technology solutions, based on business need.
• Participate/lead new projects to ensure implementation success, support BD Business Units onboarding to BDX Labeling platforms.
• Review and assessment of any new/updated regulations impacting BD product labeling.
• Engagement of key stakeholders in driving/facilitating incorporation of any resulting procedure and policy updates.
• Regular communication with labeling stakeholders and high-level monitoring of labeling activity throughout BD, with the goal of identifying trends, shared issues, and best practices.
• Collaboration with various internal functions to troubleshoot issues as they arise as well as leading solutions to resolve.
• Assess stakeholder feedback and accurately summarize with an eye toward business impact, identify and communicate resulting risks, challenges, and opportunities to leadership.
• Appropriate escalation when existing processes may not align with new requirements, and ability to inspire labeling stakeholders in building solutions.
• Builds and applies business acumen to identify relevant labeling metrics; supports regular reporting.
• Reports on key project plans, activities performed, and any obstacles.

Requirements

• Bachelor’s degree in a technical, scientific, or other related discipline required.
• Minimum of ten years overall professional experience.
• Minimum of five years of direct experience in medical device/pharmaceutical labeling including at least five years of direct experience with US, EU, and other global medical device regulations.
• 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 the 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 of working with relational databases (Excel, Power BI).
• Knowledge of quality system elements (GDP, etc.) and their interactions with ERP systems.

Tech Stack

• ERP

Benefits

• Annual Bonus and Potential Discretionary LTI Bonus
• 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
• 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, BD Deferred Compensation and Restoration Plan, 529 College Savings Plan, Financial counseling, Baxter Credit Union (BCU), Daily Pay, College financial aid and application guidance
• 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
• 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
• Bereavement leaves, Military leave, Personal leave, Family and Medical Leave (FML), Jury and Witness Duty Leave