Manager, MDS Regulatory Affairs Operations



 We are the people who give possibilities purpose 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. 

 Job Description Key Responsibilities Lead regulatory business operations activities supporting the MDS Regulatory Affairs organization. Serve as business owner and governance lead for Regulatory Information Management (RIM) systems and processes. Lead all aspects of Product Information Management (PIM) activities and ensure alignment of regulatory data with business requirements. Lead Documents of External Origin (DEO), including governance, maintenance, communication, and assessment of regulatory standards and guidance documents. Lead EUDAMED implementation, governance, compliance, and operational readiness activities. Lead Global Notification of Change (NoC) governance and associated regulatory assessment processes. Establish and maintain RIM regulatory data governance practices to ensure accuracy, consistency, and compliance. Develop and maintain regulatory metrics, dashboards, reporting tools, and operational performance indicators. Provide operational insights and recommendations to Regulatory Affairs leadership to support informed decision-making. Lead process improvement initiatives using BD Excellence and other continuous improvement methodologies. Identify, prioritize, and implement opportunities to improve efficiency, standardization, automation, and scalability of regulatory processes. Serve as the primary MDS liaison to Central Regulatory Affairs organizations. Coordinate implementation of central Regulatory Affairs initiatives and technologies across MDS. Lead change management global notifications, communication, training, and adoption activities associated with new systems, technologies, and business processes. Lead cross-functional projects supporting regulatory operations, business transformation, and organizational effectiveness. Identify operational risks, develop mitigation strategies, and escalate issues as appropriate. Support business planning, resource planning, governance reviews, and strategic operational initiatives. Ensure regulatory operational processes remain compliant, inspection-ready, and aligned with corporate requirements. Drive a culture of accountability, collaboration, operational excellence, and continuous improvement.

Bachelor's degree in Science, Engineering, Regulatory Affairs, Business Administration, Information Systems, or related discipline. 8+ years of experience in Regulatory Affairs, Regulatory Operations, Quality Systems, Business Operations, Program Management, or related medical device functions. Demonstrated experience with regulatory systems, regulatory data governance, and business process management. Experience leading initiatives and cross-functional projects. Strong knowledge of medical device regulatory processes and regulatory information management. Experience supporting digital transformation, technology deployment, and organizational change.

A Master's degree or comparable experience. Regulatory Affairs Certification (RAC). Lean Six Sigma certification. Project Management Professional (PMP) certification. Experience with regulatory systems, EUDAMED, product data governance, and enterprise regulatory technology initiatives. 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,