Sr Director, Global Product Monitoring Safety & Surveillance (Hybrid)

Company Overview

Insulet started in 2000 driven to achieve our mission of enabling our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients who have insulin-requiring diabetes, by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe.

We are looking for highly motivated, performance driven individuals who want to be part of building our Center of Excellence and be at the forefront of our rapidly growing global footprint. We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations. Our continued success depends on it.

Position Overview

The Senior Director, Global Product Monitoring (GPM) will report directly to the VP of Global Post Market Surveillance and Compliance and be responsible for the development, execution, oversight and maintenance of key aspects of Insulet’s Post Market Surveillance System consistent with applicable laws, industry standards and company policies.  They will establish systems, processes and procedures to ensure post market surveillance is optimized to enable effective utilization of product intelligence and resolution of complaint-related and other post-market quality issues. They will partner with other GPM directors, managers, and other functional leaders to manage critical post market operations and identify and prioritize initiatives to drive post market excellence, including ensuring patient safety and regulatory compliance.  They are seasoned at people management and responsible for hiring, developing, overseeing, and retaining talent in the GPM teams under their purview and for ensuring seamless coordination across cross-functional teams.  They demonstrate the ability to be strategic in quality and operational planning, people leadership, continuous improvement, process design, and program management in a highly regulated, medical technology environment and willingness to perform hands-on, technical and operations work as necessary. They work with local and global cross functional partners and regulatory bodies to ensure effective post market surveillance.

General Responsibilities

• Serves as a strong mentor, coach, people manager, leader, and subject matter expert in post-market surveillance (particularly, in post-market safety and productive engagement with regulatory authorities on post-market matters) providing both strategic and tactical direction to support growth, maintain compliance, and drive toward post-market excellence.

• Directs a global, high-performance team focused on post-market safety, surveillance, and compliance 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. Rev