Manager, Global Vigilance

Tandem Diabetes Care

8d•$110,000 - $130,000•Remote

About The Position

The Manager, Global Vigilance provides leadership and oversight for post-market surveillance (PMS) activities supporting the safety, performance, quality, and regulatory compliance of Tandem Diabetes Care’s medical devices. The role has primary responsibility for the Field Action Specialist group and global field action and Field Safety Corrective Action execution, while also supporting broader PMS activities, including vigilance and adverse event reporting, complaint analysis, trending, signal detection, regulatory reporting, and process improvement. The manager leads assigned personnel, establishes priorities, allocates work and resources, coaches and develops employees, and ensures appropriate training and coverage. The role oversees assigned PMS processes; coordinates cross-functional evaluation and communication of post-market information; and reports PMS metrics, product issues, vigilance performance, and field action status to management and governance bodies. It also oversees or supports regulatory reporting, analysis of post-market data, and global field actions from initiation through documented closure. Additional responsibilities include maintaining awareness of global requirements, supporting procedures and process improvement, audits and inspections, planning departmental resources, and ensuring staff and department compliance with applicable policies and requirements. This is a fully remote position open to candidates within the United States. Equipment will be provided and training will occur virtually. The starting base pay range is $110,000–$130,000 annually, with additional bonus and benefits. Applicants must be authorized to work for any employer in the United States; visa sponsorship is not available.

Requirements

Bachelor’s degree in engineering, life sciences, nursing, pharmacy, regulatory affairs, quality assurance, business, project management, or a related discipline, or a combination of equivalent education and applicable work experience.
Eight years of progressively responsible experience in regulated life sciences, including five years in post-market surveillance or a closely related function such as complaint management, vigilance, field actions, product safety, regulatory affairs, quality assurance, or risk management.
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, and 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.
Demonstrated experience leading complex cross-functional projects and supporting regulatory inspections, audits, or regulatory authority interactions.
Demonstrated project-management capability and ability to lead complex, cross-functional, time-sensitive activities from initiation through closure.
Strong analytical and problem-solving skills, including ability to evaluate evolving information, identify trends or data gaps, and develop evidence-based recommendations.
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.
Ability to communicate department or area issues and results within and across functional areas, and to present technical information concerning projects or timelines.
Ability to lead cooperative team efforts, organize resources to achieve team goals, and prioritize process and resource decisions based on overall team needs.

Nice To Haves

Experience with connected, software-driven, drug-delivery, durable medical equipment, or other complex medical devices.
Direct experience with medical device field actions, recalls, corrections and removals, Field Safety Corrective Actions, international vigilance reporting, complaint trending, or signal detection.
Formal project-management training or certification (e.g., PMP) and/or a quality or regulatory certification.

Responsibilities

Manage assigned Global Post-Market Surveillance personnel, with primary responsibility for the Field Action Specialist group; establish priorities, allocate work and resources, coach and develop employees, and ensure appropriate training and coverage.
Oversee assigned PMS processes, including field actions and, as assigned, vigilance reporting, complaint analysis, trending, signal detection, post-market data review, and related regulatory reporting.
Collaborate 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.
Develop, review, or present PMS metrics, significant product issues, vigilance performance, field action status, and process performance to management and applicable governance bodies.
Provide oversight or subject-matter support for global vigilance and adverse event reporting, ensuring potentially reportable events are evaluated, documented, escalated, and submitted in accordance with applicable requirements and procedures.
Support preparation, review, or approval of vigilance reports, follow-up or supplemental reports, trend reports, and regulatory authority responses, as applicable.
Review or oversee analysis of complaint, vigilance, service, field action, and other post-market data to identify potential trends, signals, or changes in known product issues and support appropriate investigation and escalation.
Lead and oversee 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.
Lead cross-functional field action teams from initiation through documented closure, defining scope, deliverables, owners, dependencies, timelines, risks, escalation pathways, and closure criteria through structured project management.
Maintain awareness of applicable global PMS requirements and support procedures, training, metrics, process improvement, audits, inspections, resource planning, and management reporting.
Support short-term department planning, including headcount, budgeting, training, and systems requirements.
Participate in staff selection, development, performance appraisal, merit recommendations, and promotion.
Ensure department staff are properly trained according to the designated training plan before assuming job responsibilities.
Develop and manage staff schedules and performance requirements.
Ensure compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.