Global Vigilance Leader - Remote

Tandem Diabetes Care, Inc.; United States; Remote; USD 110,000 - 130,000; Full time

Benefits offered by this job

Health benefits

401k with company match

Paid holidays

Job summary

Tandem Diabetes Care, Inc. is seeking a Manager, Global Vigilance to lead post-market surveillance across global operations for our medical devices. You will oversee Field Action Specialists, ensure compliance with adverse event reporting, and drive continuous improvements in vigilance processes.

The role requires extensive experience in regulated life sciences, strong leadership, and cross-functional collaboration to support regulatory inspections and timely escalation of product safety issues.

Qualifications

• Bachelor’s degree in engineering, life sciences, nursing, pharmacy, regulatory affairs, quality assurance, business, project management, or related discipline.
• Eight years in regulated life sciences with five years in PMS or similar function.
• Two years of formal people-management experience.

Responsibilities

• Lead Global Vigilance post-market surveillance and the Field Action Specialist group.
• Oversee vigilance reports, adverse events, and regulatory reporting.
• Collaborate with multiple functions to communicate post-market information.
• Develop PMS metrics and report to management and governance bodies.
• Lead global field actions, recalls, and Field Safety Corrective Actions.
• Ensure compliance with Privacy/HIPAA and regulatory requirements.

Skills

People management

Post-market surveillance

Regulatory reporting

Field actions

Vigilance

Data analysis

Project management

Cross-functional leadership

Regulatory compliance

Communication skills

Education

Bachelor’s degree in a related field

Tools

QMS software

PMP certification

Job description

Tandem Diabetes Care, Inc. is seeking a Manager, Global Vigilance to lead post-market surveillance across global operations for our medical devices. You will oversee Field Action Specialists, ensure compliance with adverse event reporting, and drive continuous improvements in vigilance processes.

The role requires extensive experience in regulated life sciences, strong leadership, and cross-functional collaboration to support regulatory inspections and timely escalation of product safety issues.