Job Description
Staff Regulatory Compliance Specialist
Job Function: Legal & Compliance
Job Sub Function: Enterprise Compliance
Job Category: Professional
Location: Ciudad Juarez, Chihuahua, Mexico
Responsibilities
- Support external audit/inspection readiness activities including logistics, room arrangements, and SME preparation.
- Coordinate external audits/inspections of the site (Notified Body, Health Authority, Ministry of Health, FDA, Regulatory Agency, or JJRC/ERC). Assess risk and applicability of audit observations from other J&J facilities.
- Lead mock external audits as part of readiness activities and provide timely information to support the audit process.
- Guide preparation of responses to regulatory agency notifications and correspondence.
- Ensure timely, adequate responses to external audit observations, including investigation, root‑cause analysis, risk assessment, corrective action plans, and monitoring of their...