Director, Regulatory Compliance - Robotics & MedTech

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

Benefits offered by this job

Paid time off

Long-term incentive program

Retirement plan (401k)

Job summary

Johnson & Johnson in Santa Clara, CA, is seeking a Director, Regulatory Compliance- RAD to provide independent regulatory oversight for robotics-enabled medical technology, software and cybersecurity, and to manage inspection readiness across the RAD scope.

The role partners with Quality, Regulatory Affairs, R&D/Engineering, Software, Product Cybersecurity, Manufacturing, Legal, and Business Leadership to identify, assess, and mitigate regulatory and quality risks, coordinate Health Authority

Qualifications

• Minimum 12 years of related experience in a regulated industry.
• Significant experience in audits or regulatory inspections and supporting manufacturing or product development teams.
• Experience with Health Authority and Notified Body inspections in an international/global context.
• Experience with software-enabled or connected medical devices, product cybersecurity, robotics/digital systems.
• Knowledge of FDA QMSR, 21 CFR Part 820, ISO 13485, EU MDR, MDSAP.
• Direct people-management experience.
• Experience with software lifecycle controls, cybersecurity, SBOMs, patching, and postmarket monitoring.

Responsibilities

• Provide independent regulatory compliance oversight for RAD products and lifecycle.
• Guide risk-based regulatory strategies across hardware/software interfaces and cybersecurity.
• Coordinate and participate in Health Authority inspections and Notified Body activities.
• Escalate risks and ensure effective remediation and governance across the organization.
• Lead or support internal audits and inspection communications and responses.

Skills

Regulatory Compliance

Education

Bachelor's degree or equivalent

Job description

Johnson & Johnson in Santa Clara, CA, is seeking a Director, Regulatory Compliance- RAD to provide independent regulatory oversight for robotics-enabled medical technology, software and cybersecurity, and to manage inspection readiness across the RAD scope.

The role partners with Quality, Regulatory Affairs, R&D/Engineering, Software, Product Cybersecurity, Manufacturing, Legal, and Business Leadership to identify, assess, and mitigate regulatory and quality risks, coordinate Health Authority