Director, Regulatory Compliance

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Legal & Compliance Job Sub Function: Enterprise Compliance Job Category: People Leader All Job Posting Locations: Santa Clara, California, United States of America Job Description: Johnson & Johnson is currently recruiting for a Director, Regulatory Compliance- RAD! This position will be located in Santa Clara, CA. Position Summary: 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, escalate, 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. Key Responsibilities: Develops and implements the RAD regulatory-compliance strategy for assigned products, sites, legal manufacturers, and quality-system processes, aligned with MedTech 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, safety/performance evidence, postmarket signals, and significant product or process changes. Challenges and evaluates the adequacy of software compliance controls for embedded software, device software functions, software accessories, cloud or remote functionality, interoperability, and modular software, including lifecycle planning, requirements, architecture, verification, validation, release, maintenance, configuration management, and change control. Assesses whether software functions and changes are appropriately governed under applicable regional requirements, including FDA device-software expectations and EU MDR software qualification/classification, and ensures material compliance gaps are escalated and remediated. Provides independent compliance oversight for AI-enabled functionality, when applicable , including lifecycle risk controls and predetermined change-control plans or analogous regulatory mechanisms. Provides independent regulatory-compliance oversight of the product-cybersecurity quality system for software-enabled and connected RAD products, while preserving the legal manufacturer’s accountability for product safety, effectiveness, design controls, and residual-risk decisions. Owns the regulatory-compliance inspection-readiness framework for assigned RAD sites and functions, including risk-based readiness assessments, mock inspections, management and SME preparedness, evidence availability, and timely remediation of identified gaps. Leads or coordinates significant Health Authority, MDSAP, and Notified Body inspections within assigned scope, including inspection strategy, escalation, cross-site coordination, and alignment with Quality, Regulatory Affairs, Legal, Operations, and business leadership. Provides independent review and oversight of inspection communications and responses , including observation interpretation, investigation depth, risk assessment, corrective and preventive actions, commitments, milestones, and evidence of implementation and effectiveness. Maintains oversight of inspection commitments through closure and uses inspection, audit, complaint, CAPA, postmarket, cybersecurity, and compliance trend data to identify systemic or recurring risk. Oversees a robust, risk-based, closed-loop internal-audit program for the assigned scope and ensures audit results inform compliance risk assessment and inspection readiness. Provides compliance oversight of significant remediation programs, special investigations, post-acquisition assessments, and field-action follow-up , including adequate scope, governance, escalation, resources, and effectiveness. Uses compliance data and regulatory intelligence to identify trends, prioritize risk reduction, and communicate actionable insights to RAD and JJRC leadership. Supports due diligence, acquisitions, integrations, divestitures, and new-product introductions , with particular attention to robotics, software, cybersecurity, technical documentation, and inspe