Director, Regulatory Compliance

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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 trans...