Manager, Global Vigilance

GROW WITH US:
Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for you to team up with us to “innovate every day,” put “people first,” and take the “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry.

STAY AWESOME:
Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology — an advanced predictive algorithm that automates insulin delivery. But we’re so much more than that. Our company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com

A DAY IN THE LIFE:

The Manager, Global Vigilance provides leadership and oversight for post-market surveillance activities supporting the safety, performance, quality, and regulatory compliance of the company’s medical devices. The role has primary responsibility for the Field Action Specialist group and global field action/FSCA execution, while also supporting broader PMS activities including vigilance and adverse event reporting, complaint analysis, trending, signal detection, regulatory reporting, and process improvement.

A Manager of Global Vigilance at Tandem also:

• Manages assigned Global Post-Market Surveillance personnel, with primary responsibility for the Field Action Specialist group; establishes priorities, allocates work and resources, coaches and develops employees, and ensures appropriate training and coverage.
• Provides oversight for assigned PMS processes, including field actions and, as assigned, vigilance reporting, complaint analysis, trending, signal detection, post-market data review, and related regulatory reporting.
• Collaborates across Complaint Management, Regulatory Affairs, Quality, Medical or Clinical Affairs, Product Safety, Engineering, Operations, Commercial, Legal, and other functions to support consistent evaluation and communication of post-market information.
• Develops, reviews, or presents PMS metrics, significant product issues, vigilance performance, field action status, and process performance to management and applicable governance bodies.
• Provides oversight or subject-matter support for global vigilance and adverse event reporting and helps ensure potentially reportable events are evaluated, documented, escalated, and submitted in accordance with applicable requirements and procedures.
• Supports preparation, review, or approval of vigilance reports, follow-up or supplemental reports, trend reports, and regulatory authority responses, as applicable to the role.
• Reviews or oversees analysis of complaint, vigilance, service, field action, and other post-market data to identify potential trends, signals, or changes in known product issues and supports appropriate investigation and escalation.
• Leads and oversees global field actions, including recalls, corrections and removals, Field Safety Corrective Actions, Field Safety Notices, product corrections, safety alerts, and other jurisdiction-specific market actions, as applicable.
• Leads cross-functional field action teams from initiation through documented closure, applying structured project management to define scope, deliverables, owners, dependencies, timelines, risks, escalation pathways, and closure criteria.
• Maintains awareness of applicable global PMS requirements and supports procedures, training, metrics, process improvement, audits, inspections, resource planning, and management reporting.
• Supports the short-term planning for the department including headcount, budgeting, training, and systems requirements.
• Participates in the selection, development, performance appraisal, merit recommendation, and promotion of staff.
• Ensures department staff is properly trained, per designated training plan, before assuming job responsibilities.
• Develops and manages schedules and performance requirements of staff.
• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.

WHERE YOU’LL WORK:

Remote: This position is fully remote and open to candidates within the United States. Equipment for the role will be provided and training will occur virtually.

WHAT YOU’LL NEED:

• Bachelor’s degree in engineering, life sciences, nursing, pharmacy, regulatory affairs, quality assurance, business, project management, or a related discipline or combination of equivalent education and applicable work experience.

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