Regulatory Compliance Manager
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. 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.
- 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.
- Strong analysis, investigation, problem solving, and root-cause analysis skills.
- Sound judgment.
- Respectful collaboration across functions and organizational levels.
- 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
- Manage the internal audit program, including the audit schedule, conducting audits, arranging follow-up activities, and confirming corrective and preventive actions.
- Coordinate preparation for external audits by regulatory agencies, notified bodies, and Enterprise Regulatory Compliance.
- Communicate relevant updates during and after external audits and review responses to external observations.
- Monitor audit measures, evaluate trends, and present practical insights to management.
- Communicate significant compliance concerns through established processes and support the implementation of new or revised standards and regulations.
- Train and assess internal auditors.
- Provide practical guidance to relevant teams and advise colleagues on regulatory requirements.
- Contribute to updates of policies, procedures, and controlled documents.
- Communicate key business issues and opportunities to management.
- Contribute to the regulatory compliance budget.
- Ensure appropriate resources are available to follow company health, safety, and environmental practices (when supervising staff).
Benefits
- Medical
- Dental
- Vision
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year (or more depending on state)
- 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))
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
