Manager, Global Vigilance

🕒 il y a 4 jours

🇺🇸 États-Unis – Télétravail

💵 $110 000 - $130 000 / an

⏰ Temps Plein

🟠 Senior

🔴 Expert

👔 Manager

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 0%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Tandem Diabetes Care

Site WebLinkedInTous les Emplois

1001 - 5000 employés

🏥 Santé

🏭 Fabrication

🔧 Matériel

Healthcare • Manufacturing • Hardware

Tandem Diabetes Care est une entreprise spécialisée dans les dispositifs médicaux qui conçoit et fabrique des pompes à insuline et des systèmes de délivrance automatisée d'insuline, alimentés par son algorithme prédictif Control-IQ+. Ses produits, y compris le t:slim X2 et le Tandem Mobi, s'intègrent avec des moniteurs de glucose en continu et des smartphones compatibles, supportent les mises à jour logicielles à distance, et sont accompagnés d'applications mobiles et cloud, de formations, ainsi que d'un support 24/7 pour aider les personnes à gérer leur traitement par insuline.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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