Regulatory Compliance Manager

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

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 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.

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.

The 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)).

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 A greement.