Associate Director, Global Regulatory Systems & Governance

Becton, Dickinson and Company; Franklin Lakes (NJ); On-site; USD 184,000 - 294,000; Full time

Benefits offered by this job

Health & well-being benefits

401(k) retirement program

Paid time off & holidays

Career development

Job summary

Becton, Dickinson and Company seeks an experienced Regulatory Affairs leader to own the MDS RA systems and data, drive governance, and ensure audit readiness across multiple platforms and regions. You will manage RIM/RIMSYS, PIM, EUDAMED, and UDI workflows, partnering with cross-functional teams to maintain lifecycle compliance and effective change control.

Ideal candidates bring 8+ years in regulated affairs, strong writing skills, and the ability to influence without direct authority.

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.
• Ability to lead through influence, make risk-based decisions, manage competing priorities, and elevate issues clearly.

Responsibilities

• Provide overall leadership and accountability for MDS RA systems, regulatory data, and enabling capabilities, establishing clear ownership and governance.
• Own the MDS RA procedure framework, including generation, approval, implementation, and harmonization across platforms.
• Serve as the MDS Audit Process Owner with evidence visibility, escalation and corrective-action oversight.
• Establish governance for MDS RA training and capability enablement, including onboarding, job aids, and training-effectiveness evaluation.
• Provide governance for RIM/RIMSYS, PIM, EUDAMED, uDI databases, PEGA workflows and related reporting tools.
• Oversee regulatory-system data quality, workflow governance, system health, reporting, and issue escalation.
• Own the end-to-end MDS Notification of Change operating framework and regulatory operations support for change control.
• Global eUMDR transition governance, readiness, risks, decisions, and SSOT data alignment across platforms.

Skills

Regulatory leadership

Regulatory data management

Audit readiness

Document control

Change control

RIM/RIMSYS

PIM

EUDAMED

UDI

PEGA RSM/DEO

RA governance

Training governance

Cross-functional collaboration

Written communication

Education

Bachelor's degree in life sciences/engineering/regulatory affairs

Master's degree or RAC/ASQ CMQ/OE certification

Regulatory affairs certification (RAC)

Tools

PEGA

SharePoint

Power BI

Job description

Becton, Dickinson and Company seeks an experienced Regulatory Affairs leader to own the MDS RA systems and data, drive governance, and ensure audit readiness across multiple platforms and regions. You will manage RIM/RIMSYS, PIM, EUDAMED, and UDI workflows, partnering with cross-functional teams to maintain lifecycle compliance and effective change control.

Ideal candidates bring 8+ years in regulated affairs, strong writing skills, and the ability to influence without direct authority.