Digital Director at Kaimera leading a team in performance marketing and managing key client relationships. Requires extensive experience in digital performance marketing and team leadership.
DF
Hybrid Senior Director, Global Product Monitoring Safety & Surveillance
Posted last month
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
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