As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
**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 Electrophysiology**
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
As Johnson & Johnson MedTech Electrophysiology, we have one goal - to ensure those with atrial fibrillation can live the lives they want. For more than 30 years, we’ve been the general market leader in the science and technology of cardiac arrythmia treatment. Our suite of tools means electrophysiologists are empowered to personalize their approaches for patients with effective and reproducible workflows. Together, we’re changing what it means to be diagnosed with atrial fibrillation or other cardiac arrhythmias.
**We are searching for the best talent for STAFF REGULATORY COMPLIANCE SPECIALIST**
**Purpose**:
Conducts audits— planned and unplanned — to verify compliance with government regulations and applicable standards, in addition to company policies and procedures. Give guidance or advice to the organization as it relates to compliance, when required.
**You will be responsible for**:
Under general direction and in accordance with all applicable federal,



state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- It ensures that Quality System Audits comply with the requirements of QSR/GMP and ISO Standards
- Conducts internal audits of the Quality System for the purpose of verifying compliance with government regulations and applicable standards, in addition to company policies and procedures. Conducts good laboratory practice (GLP) audits as required.
- Gives guidance or advice as it relates to compliance with applicable standards and regulations.
- Performs re-audits to deficient aspects and to implement corrective and preventive actions as necessary and required.
- Assigns classifications to internal audit observations and documents audit results in written reports that can be distributed and reviewed by appropriate management.
- Monitors the effectiveness of corrective actions documented in observation responses.
- You can be the lead auditor of a team of auditors, technical experts, auditors-in-training, and/or volunteer auditors.
- Reviews ownership of responses to audit observations, also acts as an advisor to other areas that are not being audited by him/her, giving advice on audit observation responses.
- Maintains audit report files, re-audit files and responses to audits carried out.
- Accompanies external auditors,



representatives of government agencies or those required by management during the execution of an applicable audit.
- Conducts audits at other J&J; sites when required by management.
- Complies with and reviews compliance metrics and communicates them to site management and the Franchise. Prepares information for Management review boards.
- Participates in the formulation of Regulatory Policies and Procedures in compliance with applicable local, state and federal standards and regulations through the development of Franchise Documents.
- It is kept up to date on government regulations and applicable standard changes through publications, participation in seminars or by collaboration with organizations.
- Responsible for communicating business related issues or opportunities to next management level
- Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed
**Qualifications / Requirements**:
- BS in science, engineering, or business.
- MBA or Master’s in Science, preferably.
- Minimum 6 years of experience in Quality, Regulatory Compliance, or related activities
- Experience in Medical Devices field or in Pharmaceuticals (preferably).
- Effective communication skills - oral and written - (English and Spanish).
- Analytical skills to interpret scientific and technical publications and legal

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