Director, Regulatory Compliance (Medical Devices)

Location: Santa Clara, California, United States of America; up to 20% domestic and international travel may be required.

Base pay: $172,000–$297,850 per year.

Company

Johnson & Johnson MedTech develops healthcare and medical-device solutions across innovative medicine and MedTech.

What you will do

• Develop and implement regulatory-compliance strategies for robotics-enabled medical technologies, software-enabled devices, connected devices, and quality-system processes.
• Provide independent advice, challenge, escalation, and oversight for product, software, cybersecurity, quality, and inspection risks.
• Monitor regulatory requirements and enforcement trends affecting robotics, device software, cybersecurity, AI-enabled functionality, and international quality systems.
• Lead inspection-readiness activities and coordinate significant Health Authority, MDSAP, and Notified Body inspections.
• Oversee inspection responses, internal audits, remediation programs, CAPA commitments, postmarket signals, and effectiveness monitoring.
• Partner with Quality, Regulatory Affairs, Engineering, Software, Cybersecurity, Manufacturing, Clinical, Legal, Supply Chain, and business leadership while developing team capability and managing assigned resources.

Requirements

• Bachelor’s degree or equivalent university degree.
• At least 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 medical-device or regulated-healthcare experience in an international or global context, including direct people-management experience.
• Experience with Health Authority or Notified Body inspections, internal-audit programs, significant compliance risks, and software-enabled or connected medical devices, robotics, digital systems, or comparable complex products.
• Knowledge of FDA QMSR, 21 CFR Part 820, ISO 13485, EU MDR, MDSAP, ISO 14971, device-software lifecycle controls, and software-change controls.
• Knowledge of product-cybersecurity lifecycle concepts, secure development, threat and vulnerability management, SBOMs, patching, and postmarket monitoring.

Culture & Benefits

• Inclusive work environment guided by the company’s Credo and equal-opportunity principles.
• Full-time employment with pension and 401(k) savings plans, subject to plan terms.
• Vacation, sick time, holiday pay, personal and family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time-off benefits.
• Eligibility for a long-term incentive program, subject to applicable plan terms.