Director, Regulatory Compliance (MedTech)

Location: Irvine, California, United States of America; the position may require 40–50% domestic and international travel.

Salary: $150,000–$258,750 per year.

Company

Johnson & Johnson MedTech develops smarter, less invasive, and more personalized healthcare treatments at the intersection of biology and technology.

What you will do

• Provide tactical and strategic regulatory compliance support for cardiovascular headquarters, manufacturing, and R&D sites.
• Lead follow-up activities for independent audits, supplier and external manufacturer assessments, field actions, significant inspections, and health authority actions.
• Analyze compliance metrics, audit findings, inspection outcomes, and emerging regulatory trends to identify and reduce risk.
• Evaluate audit observations and guide risk-based remediation and corrective action plans across regions and sites.
• Support inspection readiness at high-risk sites, including subject matter expert preparation and review of communications with health authorities.
• Represent Compliance in enterprise forums and advise on investigations, due diligence, mock inspections, divestitures, and quality system initiatives.

Requirements

• Bachelor’s degree required; a degree in science, engineering, or an equivalent field is preferred.
• At least 10 years of progressive experience in the pharmaceutical, medical device, or biotech industry.
• Extensive Quality and Regulatory Compliance experience in a global, regulated healthcare environment.
• Expert knowledge of Quality System regulations, ISO, ICH, PIC/S, and GMP requirements.
• Experience conducting GxP audits and working with global regulatory agencies, including FDA, MHRA, TGA, and notified bodies.
• Strong abilities in complex issue resolution, risk-based strategy, project management, executive communication, negotiation, and cross-functional collaboration.

Culture & Benefits

• Full-time employment within a global healthcare organization.
• Participation in pension and 401(k) savings plans, subject to plan terms.
• Eligibility for the long-term incentive program.
• Vacation, sick time, holidays, personal and family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time-off.
• Inclusive employment and interview processes with workplace accommodation support.