Sr. Regulatory Compliance Specialist

Mentor, a Johnson & Johnson Family of Companies member, is currently recruiting for a Senior Regulatory Compliance Specialist, located in Irving, TX!

Mentor is a leading supplier of breast implants in the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow breast surgery patients to improve their quality of life. The company is focused on two strategic areas: breast reconstruction and breast augmentation. MENTOR® is the only manufacturer whose silicone breast implants are in the U.S.A. For over 20 years, more than 5 million women have chosen MENTOR® Breast Implants.

Job Summary

The Senior Compliance Specialist is responsible for ensuring the robust implementation and sustainability of the compliance programs designed to protect our customers, the company, and individual employees against government allegations of fraudulent or abusive practices in the areas of research, medical, education, marketing, and selling of Johnson and Johnson products. Also, responsible for the management of the internal quality auditing process and assessment of the company's activities to verify quality system compliance and drive readiness preparation for external audits. Responsible for maintaining procedures to ensure that the compliance processes are effective and efficient in identifying, preventing, detecting, and correcting noncompliance with regulations, standards, and Company procedures. This position will provide compliance oversight in the specific areas of Internal Audits, External Audits, Compliance Intelligence, and Audit Readiness, and will be responsible for the ongoing efficiency of these systems.

Key Responsibilities

• Prepare and host external audits: e.g. Notified Body, Ministry of Health country inspections, FDA, J&J Corporate Audits for the site. Responsible for effective regulatory agency inspections.
• Audit preparation activities (auditor logistics, front-room/back-room arrangements, identifying/preparing SME’s, etc.).
• Assess the risk and applicability of audit observations from other J&J facilities to resolve the impact on the site.
• Schedule and handle mock inspections as part of External Inspection Readiness activities.
• Provide timely information to support the inspection process, including those that may be taking place at other sites/locations.
• Provide daily inspection communications regarding potential non-conformities.
• Prepare responses to any external inspection or other regulatory notification associated with the site.
• Ensure adequate corrective actions for external audit observations related to the site, including investigations, monitor and drive timely completion of CAPA plans, perform follow-up with CAPA owners, and perform effectiveness monitoring and closure.
• Establish and implement an effective internal audit schedule.
• Ensure adequate corrective actions for internal audits, including investigations and corrective action plans, drive on-time completion of CAPA plans, perform follow-up with CAPA owners, and perform effectiveness monitoring and closure
• Drive compliance and improvement in internal audit metrics.
• Ensure the quality system is periodically evaluated and audited and appropriate preventive/ corrective action is taken to meet the business and regulatory requirements.
• Where appropriate, implement the program(s) for training and evaluating the qualifications of auditors. Note: Programs can include franchise, supply chain, sector, and/or enterprise elements
• Participate in JJRC audits as requested.
• Upon receiving written notification of notified body inspections update the required compliance-related events (e.g., field actions, inspections) in CURVE per required timeframes.
• Assure that Quality & Compliance metrics are consistently and accurately collected and that metrics are gathered at the appropriate level for subsequent analysis and reporting (e.g., site level, supply chain).
• Drive compliance to Quality and Compliance metric targets.
• Create reports and communicate performance against metrics to key stakeholders.
• Highlight/communicate adverse trends in metrics and take risk-based action to remediate them.
• Proactive identification and alerting of management of quality issues in time to resolve potential adverse effects to the customer, company image/reputation, and/or the business.
• Provide input into Site Management Reviews (e.g., internal audits.) to allow relevant review.
• Proactively communicate organizational and compliance procedure/policy-related changes that may impact sites. Ensure feedback and alignment with said changes.
• Establish strong connections and collaboration with business partners at the site, e.g. Quality Operations, Training, and Manufacturing.
• Provide compliance education and training (QSR, ISO, GMPs) to the organization in support of overall educational strategies.
• Support and promote the safety and environmental objectives of the facility
• Lead-Free Sales Certificates (requests, makes copies to send to distributors and Corporate
• Administrative support for Change Notifications to BSI plus accompanying documentation