Hybrid Senior Director, Global Product Monitoring Triage – Vigilance

at Diabetes Youth Families

• Job title: Senior Director, Global Product Monitoring Triage – Vigilance
• Job type: Full Time
• Experience level: Senior
• Salary: $210,200 - $315,275 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Acton, United States

About the role

• Senior Director overseeing global product monitoring and post market surveillance at Insulet Corporation. Leading a high-performance team while ensuring compliance with industry standards and patient safety regulations.

Responsibilities

• Report directly to the VP of Global Post Market Surveillance and Compliance
• Responsible for development, execution, oversight, and maintenance of key aspects of Insulet’s Post Market Surveillance System
• Establish systems, processes, and procedures to ensure post market surveillance is optimized
• Partner with other GPM directors, managers, and functional leaders to manage critical post market operations
• Identify and prioritize initiatives to drive post market excellence and ensure patient safety
• Manage a global, high-performance team of over 50 people focusing on complaint handling
• Conduct performance appraisals and ensure development opportunities for staff
• Drive operational excellence by ensuring post-market surveillance processes reflect industry best practices
• Monitor, identify, manage, and escalate critical events and trends based on post market feedback

Requirements

• BS/BA degree with 12+ years’ work experience
• At least 8 years supervisory/people management experience in the medical devices or life sciences industry
• At least 6 years in QA/RA
• At least 4 years leading teams specifically related to medical device vigilance and/or complaint management
• Demonstrated experience in building and leading high-performing, globally distributed teams
• Experience managing individuals on a global basis across different locations and cultures
• Experience leading and directing middle managers, frontline supervisors, and individual contributors and subject matter experts
• Proven experience influencing without authority and facilitating cross-functional collaboration
• Applied knowledge of global medical device regulations
• Demonstrated experience implementing and ensuring post market processes that meet the requirements of ISO 13485, 21 CFR 820, 21 CFR 803, 21 CFR 806, EU MDR, CMDR, etc.
• Direct experience in global vigilance reporting (for example, MDR/MIR) and complaint management.

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs