Job Function: Legal & Compliance
Job Sub Function: Enterprise Compliance
Job Category:Professional
All Job Posting Locations:San Angelo, Texas, United States of America
Job Description:Employer: Ethicon, Inc.
Job Title: Staff Regulatory Compliance Engineer
Job Code:Job Location: San Antonio, TX
Job Type: Full-Time
Job Duties: Maintain a robust Compliance program to ensure compliance with all applicable quality system and regulatory requirements, company policies and procedures, and J&J Corporate requirements. Manage External and Internal Audit Program and Management Execution. Execute external and internal audits according to the established audit procedures. Ensure external and internal audit results are reported to management having responsibility for the matters audited. Carry out and lead external and internal audit and inspection readiness activities to ensure site readiness at all times including audit logistics, from room/back-room arrangements, identifying and preparing SME's, etc. Strategically support management of external and internal audits/inspections of the site. Provide guidance to ensure timely and adequate responses to internal and external 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. Assure that internal and external audit metrics are accurately captured and published. Create reports and communicate performance against metrics to key stakeholders. Highlight and communicate adverse trends in metrics and take risk-based action to remediate. Monitor and lead implementation of new and revised regulations and standards for the site. Apply comprehensive and diverse knowledge of quality systems in work assignments, projects and initiatives. Lead projects to ensure compliance with quality system and regulatory requirements. Act as emerging authority in the regulatory compliance field. Connect and collaborate with the regulatory compliance teams of other sites, regions, and business groups to attain common objectives. Provide input into Site Management Reviews and Data Review Boards (e.g., internal audits.) to allow meaningful reviews. Establish strong connection and collaboration with business partners at the site, e.g. Quality Operations, Training, and Manufacturing. Provide/coordinate regulatory compliance education and training (QSR, ISO, GMPs) to the organization in support of overall educational/training strategies. Perform performance appraisals and establish goals/objectives and development plans for direct reports. Comply with all environmental, safety and occupational health policies and ensure all direct reports comply with those requirements.
Requirements: Employer will accept a Bachelor's degree in Pharmaceutical Sciences, Industrial Management and Engineering, or related field and 8 years of Experience in the job offered or in a Staff Regulatory Compliance Engineer-related occupation.
Position requires experience in:
1. Medical device or pharmaceutical industry including regulations, standards, and (Federal and Local authority requirements).
2. Quality Management Systems (QMS) / audit-tracking software including Truvault, Windchill, VEEVA, Trackwise, ETQ, SAP, Maximo, IRIS, or OURSOURCE.
3. FDA QSR, EU MDR and IVDR.
4. GMP, QSR, ISO standards including ISO 13485.
5. Regulatory change implementation and interpreting new/revised regulations and translating them into site-level controls and procedures.
6. Internal audit program management including planning, executing and reporting internal audits and ensuring closure and tracking of findings.
7. Corrective action and problem solving, CAPA management, Root cause analysis and structured RCA techniques including 5 Whys, Fishbone, or Ishikawa.
8. Performing risk assessments and applying risk-based prioritization including FMEA and risk registers. 9. Data analysis and analytics reporting tools including Power BI.
Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA) or Lead Auditor certification
This job posting is anticipated to close on
6/2/2026.Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation -120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
- Holiday pay, including Floating Holidays -13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave - 80 hours in a 52-week rolling period10 days
- Volunteer Leave - 32 hours per calendar year
- Military Spouse Time-Off - 80 hours per calendar year
- This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement.
- For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Required Skills: Preferred Skills: 
