Manager, Global Vigilance
Tandem Diabetes Care
Summary
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.
Job description
Responsibilities
- 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.
Requirements
- 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.
- 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 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.
- 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.
- 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 a quality or regulatory certification, preferred.
Benefits
- Medical, Dental & Vision
- Health Savings Accounts
- Flexible Spending Accounts
- 11 Paid Holidays
- 20 Days PTO
- 401(k) Matching
- Employee Stock Purchase Plan
- Bonus Package
Company overview
Tandem Diabetes Care is a global medical device company specializing in advanced insulin delivery systems and diabetes management technologies. Founded in 2006 and headquartered in San Diego, California, the company has established itself as a leader in automated insulin delivery systems. Tandem's innovative product portfolio includes the Tandem Mobi system and t:slim X2 insulin pump, both featuring Control-IQ advanced hybrid closed-loop technology that significantly reduces the burden of diabetes management. The company's approach combines medical device expertise with consumer electronics design principles, creating user-friendly devices that have made Tandem the #1 recommended insulin pump brand among people living with diabetes for four consecutive years. With a workforce of 1,001-5,000 employees, Tandem operates globally, developing integrated solutions that connect insulin pumps with mobile applications and cloud-based platforms to provide comprehensive diabetes care. The company's mission focuses on creating new possibilities for patients, their loved ones, and healthcare providers through continuous innovation in diabetes technology.