Regulatory Compliance Manager

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

Job Function:

Legal & Compliance

Job Sub Function:

Enterprise Compliance

Job Category:

Professional

All Job Posting Locations:

Irvine, California, United States of America

Job Description:

Johnson & Johnson is seeking a Regulatory Compliance Manager based in Irvine, California.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Purpose:

The Regulatory Compliance Manager will strengthen quality and compliance practices across the organization. The position supports sound decision-making, effective processes, and sustained regulatory readiness. The Regulatory Compliance Manager leads the internal audit program and evaluates alignment with applicable regulations, international standards, and quality-system requirements. This position coordinates readiness and management of external audits conducted by regulatory agencies, notified bodies, and Enterprise Regulatory Compliance. This position provides leadership, clear compliance information and collaborates with cross-functional teams to achieve company goals.

Key responsibilities:

The role operates with appropriate independence and in accordance with applicable federal, state, and local requirements, as well as company procedures. Internal audit program. Responsibilities include managing the audit schedule, conducting audits directly or through qualified auditors, arranging follow-up activities when needed, and confirming that responses and corrective and preventive actions adequately address identified findings. External audit readiness. The position coordinates preparation for audits by regulatory agencies, notified bodies, and Enterprise Regulatory Compliance; communicates relevant updates during and after each audit; and reviews responses to external observations for quality and timely completion. Compliance analysis and implementation. The manager monitors audit measures, evaluates trends, and presents practical insights to management while communicating significant compliance concerns through established processes and supporting implementation of new or revised standards and regulations. Training and guidance. Duties include training and assessing internal auditors, providing practical guidance to relevant teams, advising colleagues on regulatory requirements, and contributing to updates of policies, procedures, and controlled documents. Leadership and stewardship. The role communicates key business issues and opportunities to management, contributes to the regulatory compliance budget, and, when supervising staff, helps ensure that appropriate resources are available to follow company health, safety, and environmental practices. All responsibilities are performed in accordance with applicable laws, regulations, policies, and procedures, with related assignments undertaken as business needs evolve.

Qualifications/Requirements:

A Bachelor’s or equivalent degree in Engineering, Computer Science, Business, or a related field; Master of Business Administration (MBA) is preferred but not required. Six to eight (6-8) years of relevant experience in Quality, Engineering, Regulatory Compliance, or a related function within medical devices or another regulated industry, including two to three years leading people, programs, or significant cross‑functional work. Demonstrated ability to interpret medical-device regulations and international standards, including ISO 13485, FDA QMSR, and EU MDR, and translate complex requirements into practical guidance. Clear written, verbal, and presentation skills, supported by strong analysis, investigation, problem solving, and root‑cause analysis. Sound judgment, respectful collaboration across functions and organizational levels, and a consistent quality mindset. Preferred: Lead Auditor certification from an accredited organization.

Travel:

This position requires approximately 25% travel. This role is eligible for immigration sponsorship and relocation support, if required, in accordance with Johnson & Johnson policies and local legal requirements.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

Additional Description for Pay Transparency:

• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year.
• This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement.

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com/.