Sr Regulatory Compliance Engineer

Johnson & Johnson•San Angelo, TX

9h•$79,000 - $127,650•Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com 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: SECTION 1: JOB SUMMARY The Regulatory Compliance Engineer, 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. SECTION 2: DUTIES & RESPONSIBILITIES In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: 1. External audit/inspection readiness and management. 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. 2. Internal Audit Program and Management Execution 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. 3. Enterprise, Sector and JJRC Support Participate in JJRC audits as requested. Connect and collaborate with the compliance teams of other sites, regions and business groups. 4. Metrics Collection and Reporting 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. 5. Escalations Escalate quality issues in accordance with established procedures. 6. External Standards and Regulations Support implementation of new/revised regulations and standards for the site. Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings. 7. Site Management Review and Data Review Board (DRB) Provide input into Site Management Reviews and Data Review Boards (e.g., internal audits.) to allow meaningful reviews. 8. Other tasks 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. Comply and ensure compliance of employees under area of responsibility with the Quality System regulations, standards, company policies and procedures. o Responsible for communicating business related issues or opportunities to next management level o Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. o 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 o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. o Performs other duties assigned as needed.

Requirements

Bachelor of Science degree is required, preferably in technical area.
Experience in the FDA/ISO/Health Authority-regulated industry (medical devices or pharmaceutical), regulated medical device operation preferred (see experience in Table A).
Experience in Quality, Manufacturing or Engineering roles is preferred.
Auditing experience is preferred.
Previous experience in supervisory position is preferred.
Audit and Compliance Trends
Audit Management
Audit Reporting
Business Behavior
Business Writing
Coaching
Communication
Compliance Frameworks
Compliance Management
Corporate Investigations
Critical Thinking
Legal Function
Legal Services
People Centricity
Problem Solving
Process Improvements
Risk Compliance

Responsibilities

External audit/inspection readiness and management.
Internal Audit Program and Management Execution
Enterprise, Sector and JJRC Support
Metrics Collection and Reporting
Escalations
External Standards and Regulations
Site Management Review and Data Review Board (DRB)
Other tasks

Benefits

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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits