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**Job Function**:
Legal & Compliance
**Job Sub Function**:
Enterprise Compliance
**Job Category**:
Professional
**All Job Posting Locations**:
Ciudad Juarez, Chihuahua, Mexico
**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.
**About Surgery**
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.
**We are searching for the best talent for STAFF REGULATORY COMPLIANCE SPECIALIST to be in Ciudad Juarez, Ethicon Inc.**
**Purpose**:
The Regulatory Compliance Specialist, under the supervision of the Regulatory Compliance Manager, is responsible for maintaining a robust compliance program to ensure compliance with all applicable regulatory requirements, company policies and procedures, and J&J; Corporate requirements.
**You will be responsible for**:
In accordance with all applicable federal,



state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Support external audit/inspection readiness activities to ensure site readiness at all times including audit logistics, from room/back room arrangements, identifying/preparing SME’s, etc.
- Support external audits/inspections of the site e.g. Notified Body, Health Authority, Ministry of Health, FDA, Regulatory Agency, or JJRC/ERC.
- As required, assess the risk and applicability of external audit/inspection observations from other J&J; facilities to determine impact to the site.
- Support mock external audits/inspections as part of External Audit/Inspection Readiness activities.
- Provide timely information to support the external audit/inspection process.
- Provide guidance to prepare responses to any regulatory agency notification or correspondence associated with the site.
- Provide guidance to ensure timely and adequate responses to external audit/inspection observations related to the site, including failure investigations, root cause analysis, risk assessments, correction, corrective and preventive action plans, monitor and drive on-time completion of all action plans, perform follow-up with owners, and perform effectiveness monitoring and closure.
- Ensure timely and accurate reporting and publishing of external audit metrics. Drive compliance and improvements in metrics targets.




- Execute internal audits according to the established internal audit procedures.
- Ensure internal audit results are reported to management having responsibility for the matters audited.
- Ensure timely and adequate responses to internal audit observations, including failure investigations, root cause analysis, risk assessments, correction, corrective and preventive action plans, monitor and drive on-time completion of all action plans, perform follow-up with owners, and perform effectiveness monitoring and closure
- Ensure timely and accurate reporting and publishing of internal audit metrics. Drive compliance and improvements in metrics targets.
- Ensure documentation and records related to the internal audit program are maintained.
- Ensure all quality system elements/processes applicable to the site are audited and appropriate actions are taken to meet the business and regulatory requirements.
- Participate in JJRC audits as requested.
- Connect and collaborate with the compliance teams of other sites, regions and business groups.
- Assure that internal and external audit metrics are consistently and accurately captured, and that they are reported and published at the appropriate level for subsequent analysis and reporting (e.g., site level, supply chain).
- Drive compliance and improvements in metrics targets.
- Create reports and communicate performance against metrics to key stakeholders.
- Highlight/communicate adverse trends in metrics, and take risk based action to remediate.
- Escalate quality issues in accordance with established procedures.
- Support implementation of new/revised regulations and standards for the site.
- Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and in

📌 Staff Regulatory Compliance Specialist (Ciudad Juárez)
🏢 Johnson & Johnson
📍 Ciudad Juárez