RA Labeling Compliance Lead

. 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.

Posted 4/28/2026full-timeFranklin Lakes • New Jersey • 🇺🇸 United StatesSenior💰 $132,400 - $218,400 per yearWebsite

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

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

What you’ll need

Bachelor’s degree in a technical, scientific, or other related discipline required.
Minimum of 6 years overall professional experience, with 5 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.

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

labeling technologyeIFUcontent management systemlabeling systemdata qualityregulatory compliancerelational databasesanalytical skillsquality system elementsmedical device regulations

Soft Skills

collaborationinfluencecommunicationtroubleshootingproblem-solvingstakeholder engagementbusiness acumenleadershipreportingrisk assessment