Manager, Global Vigilance

🕒 Outubro 20

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $110.000 - $130.000 / ano

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

👔 Gerente

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Tandem Diabetes Care

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🏥 Saúde

🏭 Manufatura

🔧 Hardware

Healthcare • Manufacturing • Hardware

A Tandem Diabetes Care é uma empresa de dispositivos médicos que projeta e fabrica bombas de insulina e sistemas automatizados de entrega de insulina, alimentados por seu algoritmo preditivo Control-IQ+. Seus produtos, incluindo o t:slim X2 e o Tandem Mobi, integram-se a monitores contínuos de glicose e smartphones compatíveis, suportam atualizações remotas de software e são acompanhados por aplicativos baseados em nuvem e em dispositivos móveis, além de treinamento e suporte 24 horas por dia, 7 dias por semana, para ajudar as pessoas a gerenciar a terapia de insulina.

Descrição

• Provide leadership and oversight for post-market surveillance activities supporting the safety, performance, quality, and regulatory compliance of medical devices • Manage Global Post-Market Surveillance personnel, primarily the Field Action Specialist group • Establish priorities, allocate work and resources, coach and develop employees, and ensure training and coverage • Oversee post-market surveillance processes, including field actions, vigilance reporting, complaint analysis, trending, signal detection, post-market data review, and regulatory reporting • Collaborate with Complaint Management, Regulatory Affairs, Quality, Medical or Clinical Affairs, Product Safety, Engineering, Operations, Commercial, Legal, and other functions • Develop, review, and present PMS metrics, product issues, vigilance performance, field action status, and process performance to management and governance bodies • Support evaluation, documentation, escalation, and submission of potentially reportable events • Support preparation, review, or approval of vigilance, follow-up, supplemental, trend, and regulatory authority reports • Review post-market data to identify trends, signals, changes in product issues, and support investigation and escalation • Lead global field actions, including recalls, corrections and removals, Field Safety Corrective Actions, Field Safety Notices, product corrections, safety alerts, and jurisdiction-specific market actions • Lead cross-functional field action teams from initiation through documented closure • Maintain awareness of global post-market surveillance requirements and support procedures, training, metrics, process improvement, audits, inspections, resource planning, and management reporting • Support department planning for headcount, budgeting, training, and systems requirements • Participate in staff selection, development, performance appraisal, merit recommendations, and promotions • Ensure staff training and compliance with company policies, Privacy/HIPAA, and legal and regulatory requirements

🎯 Requisitos

• Bachelor’s degree in engineering, life sciences, nursing, pharmacy, regulatory affairs, quality assurance, business, project management, or a related discipline, or equivalent education and applicable work experience • Eight years of progressively responsible experience in regulated life sciences • Five years of experience in post-market surveillance or a closely related function • Two years of formal people-management, supervisory, or equivalent team-leadership experience • Experience with electronic quality management, complaint handling, regulatory reporting, or comparable PMS systems • Proficiency with standard business applications • Broad working knowledge of medical device post-market surveillance, including field actions, complaint handling and analysis, vigilance and adverse event reporting, trending, signal detection, risk management, and quality system principles • Demonstrated people-management skills, including prioritization, delegation, coaching, performance management, and employee development • Experience leading complex cross-functional projects • Experience supporting regulatory inspections, audits, or regulatory authority interactions • Demonstrated project management capability • Strong analytical and problem-solving skills • Strong written and verbal communication skills, including regulatory, technical, customer-facing, and executive-level communications • Ability to influence and drive accountable execution across functions and regions without relying solely on direct reporting authority • Skilled in communicating department or area issues and results and presenting technical information • Skilled at leading cooperative team efforts and organizing resources to achieve team goals • Ability to make and prioritize process and resource decisions based on overall team needs • Must be authorized to work for any employer in the United States • Successful completion of pre-employment drug test and background check required • Experience with connected, software-driven, drug-delivery, durable medical equipment, or other complex medical devices preferred • Direct experience with medical device field actions, recalls, corrections and removals, Field Safety Corrective Actions, international vigilance reporting, complaint trending, or signal detection preferred • Formal project management training or certification (e.g., PMP) and/or quality or regulatory certification preferred

🏖️ Benefícios

• Medical, dental, and vision benefits available the first day • Health savings accounts • Flexible spending accounts • 11 paid holidays per year • Minimum of 20 days of paid time off, with accrual starting on day 1 • 401(k) plan with company match • Employee Stock Purchase Plan • Bonus and competitive compensation package • Fully remote work within the United States • Equipment provided • Virtual training

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