Senior Director, Global Product Monitoring Triage & Vigilance; Hybrid

Position: Senior Director, Global Product Monitoring Triage & Vigilance (Hybrid)
* Serves as a strong mentor, coach, people manager, leader, and subject matter expert in post-market surveillance (particularly, in complaint handling and vigilance reporting) providing both strategic and tactical direction to support growth, maintain compliance, and drive toward post-market excellence.
* Directs a global, high-performance team of over 50 people focused on complaint handling and vigilance while driving a culture of excellence and strategic post-market programs and processes for the organization.
* Leads people managers and individual contributors, ensuring they are effective, efficient, assisted, and supported to succeed in their roles and their continual professional development. Ensures their selection, orientation, development, and retention to carry out their responsibilities. Conducts performance appraisals and ensures development opportunities for staff.
* Maintains training and job requirements for personnel, including job descriptions/profiles, and ensures their training is completed by established due dates.
* Develops and maintains product knowledge of existing and new products and ensures team members do the same.
* Engages globally with internal and external stakeholders, developing and maintaining strong relationships to ensure effective processes while identifying improvements to drive efficiency and compliance.
* Represents GPM at cross-functional, multi-level, and external meetings.
* Drives operational excellence by helping to ensure that post-market surveillance processes and practices reflect industry best practices. Develops and maintains a culture of continuous process improvement.
* Adheres to all regulatory compliance and quality standards, including company policies and procedures and U.S. FDA, Health Canada, EU MDR, and other applicable quality system and country-specific regulations, and establishes, maintains and promotes a culture of quality with a keen focus on patient safety and customer experience.
* Maintains awareness of new or revised regulations, standards, and/or guidelines, particularly as they pertain to post-market vigilance and surveillance. Reviews changes in international laws and regulations and assesses their impact and makes recommendations to ensure compliance.
* Interfaces with notified bodies and regulatory authorities as necessary, particularly in the context of vigilance reporting, RFAIs, field actions, and audits.
* Reviews, evaluates and approves document changes, especially those concerning significant changes and revisions.
* Provides front-room and/or back-room leadership and support during inspections by regulatory authorities (such as competent authorities and notified bodies).
* Ensures follow-up on activities related to internal and external QMS audits, managing and resolving any nonconformances or other findings.
* Ensures required documentation, records, and reports are complete, accurate, and properly maintained.
* Monitors, identifies, manages, and escalates critical events, quality/safety signals, and trends and works with cross-functional partners to drive response and improvement based on post market feedback. Implements prompt actions as necessary to ensure product safety and effectiveness.
* Ensures all appropriate levels of leadership are informed of any significant concerns, action plans, and status, driving organizational awareness of key post market issues and signals.
* Identifies process improvement opportunities and, where needed, leads corrective and preventive actions (CAPAs) and other process improvements.  Works closely with internal and external stakeholders to drive the initiation of process NCs, CAPAs and supplier corrective actions (SCARs) when appropriate. Provides support or leadership to global expansion efforts.
* Ensures key performance indicators are met or exceeded and works to ensure detection of potential issues (such as, bottlenecks and backlogs) before they arise and rapidly solving issues when they do arise.
* Performs other duties as required.
* Reports to the Vice President, Global Post Market Surveillance & Compliance.
* Oversee global complaint intake, determination, and evaluation and global…