Regulatory Compliance Manager – MedTech Audit Leader

6010-Biosense Webster Inc. Legal Entity; Irvine (CA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Immigration sponsorship

Relocation support

Job summary

Johnson & Johnson seeks a Regulatory Compliance Manager in Irvine, CA to strengthen quality and compliance across the organization. You will lead internal audits, coordinate external audits, and guide teams on regulatory requirements.

The role requires 6–8 years in regulatory compliance or related fields within medical devices or regulated industries, with strong analytical and communication skills. Travel ~25% and immigration sponsorship may be available.

Qualifications

• Bachelor's degree in Engineering, Computer Science, Business or related field.
• MBA preferred but not required.
• Six to eight years in Quality, Engineering, Regulatory Compliance, or related function in medical devices or regulated industry.
• Experience leading people, programs, or cross-functional work (2–3 years).
• Ability to interpret medical-device regs and ISO 13485, FDA QMSR, EU MDR, and translate into guidance.

Responsibilities

• Lead internal audit program, manage audit schedule and follow-up.
• Coordinate external audit readiness with regulators and notified bodies.
• Monitor audit measures, identify trends and provide management with insights.
• Provide training and guidance to internal auditors and relevant teams.
• Support budgeting and resource planning for regulatory compliance.

Skills

Analytical skills

Problem solving

Communication skills

Education

Bachelor's degree

MBA preferred

Tools

Lead Auditor certification

Job description

Johnson & Johnson seeks a Regulatory Compliance Manager in Irvine, CA to strengthen quality and compliance across the organization. You will lead internal audits, coordinate external audits, and guide teams on regulatory requirements.

The role requires 6–8 years in regulatory compliance or related fields within medical devices or regulated industries, with strong analytical and communication skills. Travel ~25% and immigration sponsorship may be available.