[Hiring] Manager, Global Vigilance @Tandem Diabetes Care

Role Description

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.

• 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.

Qualifications

• 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.
• 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.
• Experience with connected, software-driven, drug-delivery, durable medical equipment, or other complex medical devices, preferred.
• 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.
• Direct experience with medical device field actions, recalls, corrections and removals, Field Safety Corrective Actions, international vigilance reporting, complaint trending, or signal detection, preferred.
• 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 the 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.
• Formal project management training or certification (e.g., PMP) and/or a quality or regulatory certification, preferred.
• Skilled at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines.
• Skilled at effectively leading a cooperative team effort and organizing resources to achieve team goals.
• Able to make and prioritize process and resource decisions based on overall team needs.

Benefits

• The starting base pay range for this position is $110,000 - $130,000 annually.
• Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate’s location and the overall job market.
• Tandem offers health care benefits such as medical, dental, vision available your first day, as well as health savings accounts and flexible saving accounts.
• You’ll also receive 11 paid holidays per year, a minimum of 20 days of paid time off (with accrual starting on day 1).
• You will have access to a 401k plan with company match as well as an Employee Stock Purchase plan.

Company Description

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.

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.