Manager, MDS Regulatory Affairs Operations

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Job Description

• 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 escalates risks 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.

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