Regulatory Compliance Manager

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

Benefits offered by this job

Vacation hours

Sick time

Floating holidays

Parental leave

Bereavement leave

Volunteer leave

Military spousal time-off

Job summary

Johnson & Johnson is seeking a Regulatory Compliance Manager based in Irvine, California. The role strengthens quality and compliance practices, leads the internal audit program, and coordinates readiness for external audits by regulatory agencies. Travel is approximately 25%.

Additional description covers collaboration across cross‑functional teams and ongoing compliance improvements. The incumbent will provide leadership, guidance, and budgetary input to ensure regulatory readiness and

Qualifications

• Bachelor’s degree or equivalent in Engineering, CS, Business or related field.
• MBA preferred but not required.
• 6–8 years of relevant experience in Quality, Engineering, Regulatory Compliance or related field.

Responsibilities

• Lead internal audit program and schedule, oversee audits and CAPAs.
• Coordinate readiness and responses for external audits by regulators and notified bodies.
• Monitor and improve compliance processes; implement updated standards and regulations.
• Train and guide internal auditors; provide regulatory guidance to teams.

Skills

Regulatory compliance considerations

Audit management

Risk assessment

Cross-functional leadership

Education

Bachelor’s or equivalent in Engineering/CS/Business

MBA (preferred)

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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.

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.

Anticipated base pay range for this position is

$102,000.00 - $177,100.00

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)).

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.