Regulatory Compliance Manager

Johnson & Johnson•Irvine, CA

3d•Onsite

About The Position

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.

Requirements

A Bachelor’s or equivalent degree in Engineering, Computer Science, Business, or a related field.
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.

Nice To Haves

Master of Business Administration (MBA) is preferred but not required.
Lead Auditor certification from an accredited organization

Responsibilities

Managing the internal 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.
Coordinating preparation for audits by regulatory agencies, notified bodies, and Enterprise Regulatory Compliance; communicating relevant updates during and after each audit; and reviewing responses to external observations for quality and timely completion.
Monitoring audit measures, evaluating trends, and presenting practical insights to management while communicating significant compliance concerns through established processes and supporting implementation of new or revised standards and regulations.
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.
Communicating key business issues and opportunities to management, contributing to the regulatory compliance budget, and, when supervising staff, helping ensure that appropriate resources are available to follow company health, safety, and environmental practices.

Benefits

Medical
Dental
Vision
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Consolidated retirement plan (pension)
Savings plan (401(k))