Medical Device Regulatory Compliance Lead

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

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