Director, MedTech Regulatory & Cybersecurity Compliance

6267-Auris Health Inc. Legal Entity; Santa Clara (CA); On-site; USD 172,000 - 298,000; Full time

Job summary

Johnson & Johnson in Santa Clara, CA, seeks a Director, Regulatory Compliance- RAD to provide independent, strategic regulatory compliance oversight for robotics-enabled medical technology, software, and cybersecurity.

You will lead inspection-readiness, coordinate Health Authority, MDSAP, and Notified Body activities, and partner across Quality, Regulatory Affairs, Legal, and R&D to mitigate regulatory risk.

Qualifications

• Education: A minimum of Bachelor’s or equivalent University degree is required.
• Minimum 12 years of related experience in a regulated industry, including at least 5 years performing, leading, or managing quality-system/GMP audits or regulatory inspections.
• Significant experience in medical devices or another regulated healthcare environment, operating in an international or global context.
• Demonstrated experience with software-enabled or connected medical-device compliance, product cybersecurity, robotics/digital systems, or an equivalent complex electromechanical/software product environment.

Responsibilities

• Develops and implements the RAD regulatory-compliance strategy for assigned products, sites, legal manufacturers, and quality-system processes.
• Provides independent compliance advice, challenge, and escalation on significant product, software, cybersecurity, quality-system, and inspection risks; ensures that risk decisions are transparent and appropriately governed.
• Represents RAD Regulatory Compliance in risk-management boards, quality-review boards, management reviews, governance forums; escalates material risks to the Senior Director.

Skills

Regulatory compliance

Quality-system audits

Regulatory inspections

Software in medical devices

Cybersecurity in medical devices

Leadership/people management

Education

Bachelor’s or equivalent University degree

Job description

Johnson & Johnson in Santa Clara, CA, seeks a Director, Regulatory Compliance- RAD to provide independent, strategic regulatory compliance oversight for robotics-enabled medical technology, software, and cybersecurity.

You will lead inspection-readiness, coordinate Health Authority, MDSAP, and Notified Body activities, and partner across Quality, Regulatory Affairs, Legal, and R&D to mitigate regulatory risk.