Johnson & Johnson MedTech · 15 hours ago
Sr Regulatory Compliance Engineer
San Angelo, TX
Full-time
Onsite
Senior Level
$79K/yr - $128K/yrJohnson & Johnson MedTech is committed to healthcare innovation, aiming to build a world where complex diseases are effectively managed. The Sr Regulatory Compliance Engineer is responsible for maintaining a robust compliance program to meet regulatory requirements and corporate policies, ensuring the organization is prepared for audits and inspections.
Hospital & Health Care
Responsibilities
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
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 industry meetings
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
Comply and ensure compliance of employees under area of responsibility with the Quality System regulations, standards, company policies and procedures
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
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
Qualification
Required
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
Experience in Quality, Manufacturing or Engineering roles is preferred
Auditing experience is preferred
Previous experience in supervisory position is preferred
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
Benefits
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
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
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
Founded in 1886
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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