Director, Global Regulatory Affairs & Systems

Becton Dickinson; Franklin Lakes (NJ); On-site; USD 150,000 - 190,000; Full time

Job summary

Becton Dickinson in the United States is seeking an experienced leader to own the MDS Regulatory Affairs (RA) systems, governance, and data. You will manage procedure frameworks, audits, and training programs while coordinating with RIM, PIM, EUDAMED, and UDI regulatory activities across platforms.

You will drive governance for regulatory data quality, change control, and lifecycle compliance, ensuring readiness for audits and regulatory submissions.

Qualifications

• Bachelor’s degree in life sciences, engineering, regulatory affairs, quality, information systems, or a related discipline.
• 8+ years progressive experience in medical device Regulatory Affairs, Quality, regulatory operations, or regulated systems/process management.
• Demonstrated experience leading regulatory or quality processes across multiple functions, platforms, sites, or regions.
• Working knowledge of medical device QMS expectations, audit readiness, document control, change control, regulatory data, UDI, and lifecycle compliance.
• Experience with regulated system governance, business process ownership, requirements definition, validation or testing support, data quality, and user adoption.
• Strong written communication skills, including authoring procedures, work instructions, governance documents, training materials, and executive updates.

Responsibilities

• Provide overall leadership and accountability for MDS RA systems, processes, data, and enabling capabilities.
• Own the MDS RA procedure framework, including generation, alignment, approval, implementation, and harmonization.
• Serve as the MDS RA Audit Process Owner with evidence visibility and corrective-action oversight.
• Establish governance for MDS RA training, onboarding, and training-effectiveness evaluation.
• Provide governance for RIM/RIMSYS, PIM, EUDAMED, eIPRRA, PEGA RSM/DEO, RAIBot, and related reporting tools.
• Oversee regulatory-system data quality, workflow governance, system health, and metrics.
• Own MDS governance for Documentation of External Origin and regulatory intelligence.
• Provide governance for Global UDI and MDS product data across databases and jurisdictions.
• Oversee FDA annual establishment registration and device listing with escalation of gaps.
• Own end-to-end MDS Notification of Change framework and regulatory operations support.
• Provide MDS leadership for Global eUMDR transition with cross-functional alignment.

Skills

Leadership

Governance

Regulatory data

Audit readiness

Change control

Documentation

Executive updates

Influence & decisions

Education

Bachelor's degree in life sciences, engineering, regulatory affairs, quality, information systems, or related

Master’s degree or regulatory certification (preferred)

Tools

PEGA RSM/DEO

PIM

EUDAMED

GUDID

Power BI

Job description

Becton Dickinson in the United States is seeking an experienced leader to own the MDS Regulatory Affairs (RA) systems, governance, and data. You will manage procedure frameworks, audits, and training programs while coordinating with RIM, PIM, EUDAMED, and UDI regulatory activities across platforms.

You will drive governance for regulatory data quality, change control, and lifecycle compliance, ensuring readiness for audits and regulatory submissions.