Hybrid Senior Director, Global Product Monitoring Safety & Surveillance

at Diabetes Youth Families

• Job title: Senior Director, Global Product Monitoring Safety & Surveillance
• Job type: Full Time
• Experience level: Senior
• Salary: $193,800 - $290,700 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Assembly
• Location requirements: Hybrid, Acton, United States

About the role

• Senior Director of Global Product Monitoring overseeing product safety and post-market compliance for innovative medical devices. Leading a high-performance global team and engaging regulatory authorities.

Responsibilities

• Oversee global post-market professionals responsible for the timely and effective management, preparation, and assembly of information for post-market requests for additional information (RFAIs) or other authority inquiries related to marketed products.
• Help write these responses and facilitate engagement or engage with regulatory authorities as needed.
• Author and/or approve response communications to inquiries and requests from regulatory authorities around the world.
• Direct and ensure back-up of the French local contact for vigilance (matériovigilance) and oversee transmission of French incidents to the French local contact for matériovigilance.
• Lead, mentor, and further develop a product/patient safety capability that applies clinical experience across the entire post market surveillance system.
• Maintain and/or utilize reports and dashboards to identify and manage post-market safety, surveillance, and compliance activities.

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 post-market surveillance, pharmacovigilance, and/or patient safety
• 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.
• Excellent written and verbal communication skills; ability to communicate effectively with and influence people at all levels of the organization.

Benefits

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