Regulatory Compliance Manager, MedTech Audits & Readiness

Johnson and Johnson; Irvine (CA); On-site; USD 102,000 - 177,000; Full time

Benefits offered by this job

Relocation assistance

Immigration sponsorship

Job summary

Johnson & Johnson in Irvine, California is seeking a Regulatory Compliance Manager to strengthen quality and compliance practices across the organization. The role leads the internal audit program and coordinates readiness for external audits by regulatory bodies and Enterprise Regulatory Compliance.

The ideal candidate has 6–8 years in Quality, Engineering or Regulatory Compliance in medical devices, with strong analytical and communication skills, and travel around 25% is required.

Qualifications

• Bachelor’s or equivalent degree in a relevant field.
• 6–8 years of experience in Quality, Engineering, Regulatory Compliance, or related function within medical devices or a regulated industry, including 2–3 years leading people or programs.
• Ability to interpret medical-device regulations and international standards (ISO 13485, FDA QMSR, EU MDR).
• Strong written, verbal, and presentation skills with solid analytical ability.
• Willingness to travel approximately 25%.

Responsibilities

• Manage the internal audit program, audit scheduling, and corrective actions.
• Coordinate readiness for external audits by regulatory agencies and notified bodies.
• Conduct compliance analysis and present actionable insights to management.
• Train and guide internal auditors and collaborate with cross-functional teams.
• Assist in budgeting and governance for regulatory compliance activities.

Skills

Regulatory compliance

Auditing

Quality systems

Leadership

Regulatory interpretation

Communication

Education

Bachelor's degree in Engineering, CS, or Business

MBA preferred

Tools

Lead Auditor certification

Job description

Johnson & Johnson in Irvine, California is seeking a Regulatory Compliance Manager to strengthen quality and compliance practices across the organization. The role leads the internal audit program and coordinates readiness for external audits by regulatory bodies and Enterprise Regulatory Compliance.

The ideal candidate has 6–8 years in Quality, Engineering or Regulatory Compliance in medical devices, with strong analytical and communication skills, and travel around 25% is required.