Regulatory Compliance Manager

Johnson & Johnson Family of Companies is recruiting for a Regulatory Compliance Manager! This position will be located in Irving, TX.

Mentor Worldwide, LLC, a member of Johnson & Johnson's Medical Devices Companies, is recruiting for a Regulatory Compliance Manager for our Irving, Texas location!

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 made in the U.S.A. For over 20 years, more than 5 million women have chosen MENTOR® Breast Implants.

• Lead and manage site audit readiness activities to ensure inspection readiness at all time
• Prepare and host external audits: e.g. Notified Body, Ministry of Health country inspections, FDA, J&J Corporate Audits for 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 determine impact to the site.
• Schedule and manage mock inspections as part of External Inspection Readiness activities.
• Provide timely information to support the inspection process, including those that maybe 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 site.
• Ensure adequate corrective actions for external audit observations related to site, including investigations, monitor and drive on-time completion of CAPA plans, perform follow-up with CAPA owners, and perform effectiveness monitoring and closure.

• Curriculum and Proficiency Establish and execute an effective internal audit schedule for site.
• Execute against established internal audit procedures.
• 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 quality system is periodically evaluated and audited and appropriate preventive/ corrective action is taken to meet the business and regulatory requirements.
• Where appropriate, execute program(s) for training and evaluating qualifications of auditors. Note: Programs can include franchise, supply chain, sector, and/or enterprise elements.

• Participate in JJRC audits as requested.
• Where appropriate assure representation on all required business unit, sector, and/or enterprise teams (e.g., Do it Right)
• Support the creation and effective deployment of internal J&J Quality System and/or Compliance standards.
• Connect and collaborate with CSS Regulatory Compliance team and other regions.

• Assure that required compliance-related events (e.g., field actions, inspections) are entered into CURVE per required timeframes.
• Assure that CURVE information is current and updated in a timely manner.

• Assure that Quality & Compliance metrics are consistently and accurately captured, and that metrics are captured 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.

• Escalate items in accordance with established procedures.
• Provide routine communication, updates and escalation to site and franchise organizational management regarding compliance trends and initiatives.
• Responsible for the 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.

• Proactively assess and influence the external environment by participating on industry and regulatory body work teams. As appropriate collect and provide site input.
• Communicate outcomes and trends to key stakeholders.
• Support implementation of new external standards/regulations for Supply Chain Sites.
• Maintain current knowledge of regulatory changes through industry publications,

• Provide input into Site Management Reviews (e.g., internal audits.) to allow meaningful review.

• Proactively communicate organizational and compliance procedure/ policy related changes that may impact sites. Ensure feedback and alignment with said changes.
• Establish strong connection and collaboration with business partners at the site, e.g.
• Quality Operations, Training, Manufacturing.
• Provide compliance education and training (QSR, ISO, GMPs) to the organization in support of overall educational strategies.
• As appropriate, perform annual performance appraisals for identified associates.
• Establish objectives and development plans for direct reports
• Support and promote the safety and environmental objectives of the facility
• Responsible for communicating business related issues or opportunities to next management level
• 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
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

• Bachelor's Degree and 5-10 years in Regulatory Compliance, Quality roles and Medical Device Industry, including 2-3 years specific experience in a management/supervisory role.
• Working Knowledge of 21 CFR Part 820, QSR, ISO 13485, SOR 98-282 CMDR (Canada Medical Device Regulations, J-PAL (Japanese), MDD (European) requirements, and knowledge of Brazil GMP and other applicable regulations and standards. Experience in Medical Device Industry.

• Experience, supporting and managing Health Authority & Notified Body Inspections, managing internal audit program, expertise in ISO 13485, EUMDR, FDA CFR 820 is a must.
• Excellent communication skills, able to quickly build credibility within the Compliance community, executive management, external regulators, and industry.
• Strong collaboration and influence management skills to partner effectively with Sector functions and across Operating Units.
• Proven track record of demonstrating collaboration across the organization and at all levels.
• Balanced technical understanding of products and processes combined with superior business and compliance acumen.
• Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results.
• Ability to recognize, build support for change and engage in constructive conflict.
• High tolerance for ambiguity in a complex environment.
• Ability to make the complex clear and easily understood by others
• Able to generate enthusiasm for best-in-class performance through the clear personal passion to be the best in these areas.
• Ability to build partnerships both internally and externally
• Capacity to put the customer central to all thinking.
• Ability to discern critical issues amidst broad operating unit complexity and to engage and achieve executive management support for proactive and reactive measures