Director, Regulatory Compliance

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Legal & Compliance

Enterprise Compliance

People Leader

Santa Clara, California, United States of America

Johnson & Johnson is currently recruiting for a Director, Regulatory Compliance- RAD! This position will be located in Santa Clara, CA. The Director, Regulatory Compliance – RAD provides independent, strategic regulatory compliance oversight for the RAD business, with particular emphasis on robotics-enabled medical technology, software and software-enabled devices, connected-device and product-cybersecurity compliance, and Health Authority/Notified Body inspection readiness and management. The Director interprets current and emerging regulatory requirements, standards, and regulator expectations;

translates them into risk-based compliance strategies; and provides independent advice, challenge, escalation, and oversight across the product and quality-system lifecycle. The role partners with Quality, Regulatory Affairs, R&D/Engineering, Software, Product Cybersecurity, Manufacturing/Operations, Clinical, Legal, Supply Chain, and business leadership to identify, assess, communicate, elevate, and oversee mitigation of material quality and regulatory-compliance risks. The Director leads inspection-readiness strategy and coordinates significant Health Authority, MDSAP, and Notified Body inspection-management activities for the assigned RAD scope.

The role provides oversight of inspection responses, remediation, internal-audit follow-up, and effectiveness monitoring, and may act as delegate to the Senior Director, Regulatory Compliance when formally assigned.

• Develops and implements the RAD regulatory-compliance strategy for assigned products, sites, legal manufacturers, and quality-system processes, aligned with Med Tech Quality & Compliance and JJRC strategies.
• Provides independent compliance advice, challenge, and escalation on significant product, software, cybersecurity, quality-system, and inspection risks; ensures that risk decisions, ownership, rationale, and required actions are transparent and appropriately governed.
• Monitors the external regulatory environment for requirements and enforcement trends affecting robotics, connected devices, device software, cybersecurity, AI-enabled functionality where applicable, quality systems, and inspections; assesses business impact and drives timely implementation plans.
• Represents RAD Regulatory Compliance in designated risk-management boards, quality-review boards, management reviews, product-development governance, compliance councils, and leadership forums; escalates material risks to the Senior Director and appropriate governance bodies.
• Provides compliance oversight across the lifecycle of robotics-enabled and computer-assisted medical-device systems, including system integration, hardware/software interfaces, usability and training controls,…