Director, MedTech Regulatory Compliance & Robotics

Johnson Johnson; Santa Clara (CA); On-site; USD 172,000 - 298,000; Full time

Benefits offered by this job

Vacation –120 hours per calendar year

Parental Leave – 480 hours within one…

401(k) retirement plan and other post‑

Job summary

Johnson & Johnson is seeking a Director, Regulatory Compliance- RAD in Santa Clara, CA. The role centers on strategic, independent regulatory oversight for robotics-enabled medical technology, software and cybersecurity compliance, and inspection readiness across the RAD scope.

The candidate will translate evolving regulatory requirements into risk-based compliance strategies, collaborate with Quality, Regulatory Affairs, R&D/Engineering, Software, Product Cybersecurity,

Qualifications

• Minimum 12 years of related experience in a regulated industry.
• Significant experience in medical devices or regulated healthcare, with international context.
• Experience supporting Health Authority/Notified Body inspections and internal audits.
• Experience with software-enabled or connected medical-device compliance, cybersecurity, robotics/digital systems.

Responsibilities

• Develop RAD regulatory-compliance strategy for products, sites and quality-system processes.
• Provide independent compliance advice and escalation on product, software and cybersecurity risks.
• Monitor regulatory environment and translate requirements into action plans.
• Represent RAD Regulatory Compliance in governance boards and leadership forums.
• Oversee lifecycle compliance for robotics-enabled and software-enabled medical devices.
• Assess software functions and changes under FDA/EU rules; ensure remediation of gaps.
• Provide oversight of product-cybersecurity quality systems and inspection-readiness.
• Lead or coordinate Health Authority, MDSAP, and Notified Body inspections.

Education

Bachelor’s or equivalent University degree

Job description

Johnson & Johnson is seeking a Director, Regulatory Compliance- RAD in Santa Clara, CA. The role centers on strategic, independent regulatory oversight for robotics-enabled medical technology, software and cybersecurity compliance, and inspection readiness across the RAD scope.

The candidate will translate evolving regulatory requirements into risk-based compliance strategies, collaborate with Quality, Regulatory Affairs, R&D/Engineering, Software, Product Cybersecurity,