Sr Regulatory Compliance Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 SMEs 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.

SECTION 3: EXPERIENCE AND EDUCATION*

o Bachelor of Science degree is required preferably in technical area.

o Experience in the FDA/ISO/Health Authority-regulated industry (medical devices or pharmaceutical) regulated medical device operation preferred (see experience in Table A).

o Experience in Quality Manufacturing or Engineering roles is preferred.

o Auditing experience is preferred.

o Previous experience in supervisory position is preferred.

Required Skills:

Preferred Skills:

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

The anticipated base pay range for this position is :

$79000.00 - $127650.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).



This position is eligible to participate in the Companys 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: - Experience:

Senior IC