Regulatory Operations Lead — RIM & Data Governance

Regulatory Jobs; Franklin Lakes (NJ); On-site; USD 138,000 - 220,000; Full time

Benefits offered by this job

Medical coverage

401(k) Plan

Paid time off

Life and AD&D insurance

Disability insurance

Educational assistance

Job summary

BD is seeking a regulatory operations leader to drive governance of regulatory information systems and data, oversee PIM activities, and align regulatory data with business needs. You will lead EUDAMED readiness, NoC governance, and cross-functional initiatives across MDS to ensure compliance and efficiency.

The role requires 8+ years in regulatory affairs, expertise in RIM/PIM, and experience with digital transformation.

Qualifications

• Bachelor's degree in a relevant field and 8+ years in regulatory affairs or related medical device functions
• Experience with regulatory systems, data governance, and business process management
• Leadership of cross-functional initiatives and projects
• Strong knowledge of medical device regulatory processes and regulatory information management
• Experience with digital transformation, technology deployment, and organizational change

Responsibilities

• Lead regulatory operations for MDS Regulatory Affairs
• Govern regulatory information management systems and processes
• Oversee Product Information Management alignment of regulatory data with business needs
• Manage DEO governance and regulatory standards
• Lead EUDAMED implementation and readiness
• Govern NoC processes and regulatory assessments
• Establish data governance practices for regulatory data
• Develop regulatory metrics and dashboards for leadership
• Provide insights to Regulatory Affairs leadership for decisions
• Drive process improvement using BD Excellence and other methods
• Identify opportunities to improve efficiency, standardization, and automation
• Coordinate centralized regulatory initiatives across MDS
• Lead change management for new systems and processes
• Lead cross-functional projects supporting regulatory operations
• Identify risks and mitigation strategies
• Support business planning and governance reviews
• Ensure processes remain compliant and inspection-ready
• Foster accountability and collaboration

Skills

Regulatory affairs knowledge

Regulatory operations

Quality systems

Business operations

Program management

Digital transformation

Leadership

Cross-functional collaboration

Education

Bachelor's degree in Science/Engineering/Regulatory Affairs/Business Administration/Information Systems

Master's degree or comparable experience

Regulatory Affairs Certification (RAC)

Lean Six Sigma certification

Project Management Professional (PMP) certification

Tools

Regulatory Information Management (RIM) systems

Product Information Management (PIM)

EUDAMED

Regulatory data governance

Job description

BD is seeking a regulatory operations leader to drive governance of regulatory information systems and data, oversee PIM activities, and align regulatory data with business needs. You will lead EUDAMED readiness, NoC governance, and cross-functional initiatives across MDS to ensure compliance and efficiency.

The role requires 8+ years in regulatory affairs, expertise in RIM/PIM, and experience with digital transformation.