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Hybrid Senior Director, Global Product Monitoring Triage – Vigilance
Posted last month
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
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