Regulatory Compliance Manager (MedTech)

Location: Irvine, California, United States of America. Approximately 25% travel is required. Relocation support and immigration sponsorship may be available in accordance with company policies and local legal requirements.

Salary: $102,000–$177,100 per year.

Company

Johnson & Johnson MedTech develops smarter, less invasive, and more personalized healthcare treatments at the intersection of biology and technology.

What you will do

• Lead the internal audit program, including audit scheduling, execution, follow-up, and review of corrective and preventive actions.
• Coordinate preparation for audits conducted by regulatory agencies, notified bodies, and Enterprise Regulatory Compliance.
• Monitor audit metrics, evaluate compliance trends, and present practical insights and significant concerns to management.
• Support implementation of new or revised standards, regulations, policies, procedures, and controlled documents.
• Train and assess internal auditors, provide regulatory guidance, and collaborate with cross-functional teams.
• Communicate business risks and opportunities to management and contribute to the regulatory compliance budget.

Requirements

• Bachelor’s degree or equivalent in Engineering, Computer Science, Business, or a related field.
• Six to eight years of relevant experience in Quality, Engineering, Regulatory Compliance, or a related function within medical devices or another regulated industry.
• Two to three years of experience leading people, programs, or significant cross-functional work.
• Ability to interpret medical-device regulations and international standards, including ISO 13485, FDA QMSR, and EU MDR.
• Strong written, verbal, presentation, analytical, investigative, problem-solving, and root-cause analysis skills.
• Sound judgment, respectful cross-functional collaboration, and a consistent quality mindset.

Nice to have

• MBA degree.
• Lead Auditor certification from an accredited organization.

Culture & Benefits

• Medical, dental, vision, retirement pension, and 401(k) savings plan benefits.
• Paid vacation, sick time, holidays, personal and family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time off.
• Inclusive work environment with equal employment opportunity and applicant accommodation support.
• Work is performed in accordance with applicable health, safety, environmental, legal, regulatory, and company requirements.