RA Labeling Compliance & Business Solutions Lead

Job Description Summary Job Description We are the makers of possible    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.    We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.  The RA Labeling Compliance and Business Solutions Lead will partner with labeling teams, stakeholder groups, and leadership in assessing new challenges and helping to identify and implement solutions. This role reports to BD’s Central Regulatory Affairs team and provides the RA Labeling Compliance and Business Solutions Lead the platform to support BD as the Global Process Owner for eIFU. In addition to being accountable for management of BD’s eIFU website solution, this role is responsible for supporting the onboarding of new BD business units to the eIFU site, supporting ongoing solution compliance and site use, and identifying new, related, opportunities. Additional BD-wide labeling responsibilities include supporting the development, deployment, and management of BD-wide labeling software solutions, and engagement with all labeling teams to identify areas of opportunity and to bring the Voice of Regulatory to system and process improvements within the product labeling space. The ability to socialize change to upstream and downstream stakeholders is essential; additional responsibilities include utilizing problem-solving skills to support the processes governing labeling solutions, identifying, and monitoring labeling metrics, and building and supporting BD’s internal labeling communications network. This position reports directly to the Director, Central Regulatory Affairs. Job Responsibilities: 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. Leadership Expectations: Ability to create a sense of energy, excitement, and personal commitment to the organization by empowering others, rewarding, and celebrating superior performance, and creating an inclusive workplace across multiple locations. Be an advocate for Regulatory Labeling; communicate confidently with peers, subordinates, and superiors. Skilled in distilling critical information and delivering simple, clear messaging. Coordinate with peers across BD to establish, communicate, and engage them in the vision & strategy of labeling initiatives, and build consensus for process harmonization. Establish, build, and successfully manage relationships with partners in stakeholder organizations. Demonstrate logical thought processes and use of common sense to reach workable solutions. Honors all commitments and fulfills obligations; leads with integrity and professionalism. Inspires responsibility for compliance with rules and regulations among peers. Education and Experience required: 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. 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 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. Preferred Qualifications Medical Device, IVD, Pharmaceutical experience strongly preferred Physical Demands Ability to travel approximately 25% US and OUS, or as needed. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. 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 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 Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.   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 health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.   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. Required Skills Optional Skills . Primary Work Location USA NJ - Franklin Lakes Additional Locations Work Shift At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $132,400.00 - $218,400.00 USD Annual