Manager, MDS Regulatory Affairs Operations

Becton Dickinson seeks a Manager of MDS Regulatory Affairs Operations to lead regulatory business operations, systems governance, and process improvements. The role manages regulatory information management, product data, compliance activities, and serves as a key liaison between divisional and central regulatory organizations.

Responsibilities

• Lead regulatory operations activities and serve as governance lead for Regulatory Information Management systems
• Oversee Product Information Management activities and regulatory data alignment with business requirements
• Manage Documents of External Origin governance and EUDAMED implementation across the organization
• Establish data governance practices, develop regulatory metrics, dashboards, and performance reporting tools
• Identify and implement process improvements, automation opportunities, and efficiency enhancements

Requirements

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