Director, Regulatory Compliance
Johnson & Johnson · Santa Clara, CA
The apply link worked recently (not employer-confirmed).
Role summary
Johnson & Johnson seeks a Director of Regulatory Compliance for its Robotics and Digital Solutions business in Santa Clara, California. This role provides strategic oversight of regulatory compliance for robotics-enabled medical devices, software, and connected products, with responsibility for Health Authority inspection readiness and cross-functional risk management.
Where this listing comes from
This listing was compiled by RoleLantern from the employer's publicly available posting on Workday, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-04 (originally posted 2026-10-04). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.
What they're looking for
- Extensive experience in medical device regulatory compliance and quality systems
- Deep knowledge of FDA, EU MDR, and MDSAP regulatory frameworks
- Expertise in software compliance, cybersecurity controls, and device-software requirements
- Demonstrated leadership in cross-functional governance and risk-management boards
- Experience managing Health Authority and notified-body inspections
- Strong background in robotics, connected devices, or AI-enabled medical technology
What you'll be doing
- Develop and implement regulatory-compliance strategy for robotics-enabled medical devices and software-enabled products
- Provide independent compliance oversight and challenge across product lifecycle, quality systems, and inspection readiness
- Monitor external regulatory environment for emerging requirements affecting robotics, software, cybersecurity, and AI functionality
- Lead and coordinate Health Authority, MDSAP, and notified-body inspections; oversee responses and remediation
- Represent regulatory compliance in risk-management boards, quality reviews, and leadership governance forums
Privacy & handoff
This role links to Johnson & Johnson's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.