Manager, Global Vigilance

Tandem Diabetes Care, Inc.; EE. UU.; A distancia; USD 110.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health benefits

401k with company match

Paid holidays

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

People management

Post-market surveillance

Regulatory reporting

Field actions

Vigilance

Data analysis

Project management

Cross-functional leadership

Regulatory compliance

Communication skills

Educación

Bachelor’s degree in a related field

Herramientas

QMS software

PMP certification

Descripción del empleo

Manager, Global Vigilance# Careers## Manager, Global VigilanceApply: Fully Remote: Remote US: Full time: Posted 4 Days Ago: JR101613**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.* 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.**COMPENSATION & 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. In addition to base pay, Tandem offers a competitive compensation package that includes bonus and a robust benefits package. 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) and you will have access to a 401k plan with company match as well as an Employee Stock Purchase plan. Learn more about Tandem’s benefits here! **YOU SHOULD KNOW:**Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a pre-employment screening process comprised of a drug test (excluding marijuana) and background check, which includes a review of criminal history information. Tandem has good cause to conduct a review of criminal history information of candidates for this position, as this role may involve access to proprietary, sensitive and/or confidential information, including customer protected health information. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders. **SPONSORSHIP:** Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.**WHY YOU’LL LOVE WORKING HERE:** At Tandem, we believe joy fuels excellence. That's why we've built a workplace that celebrates your achievements and supports your well-being. Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie. This is just one of the ways we stay awesome! Explore the benefits and reasons to love Tandem at https://www.tandemdiabetes.com/careers.**BE YOU, WITH US!**We embrace the value that every single one of us brings to the table. But sometimes we forget that when we don’t meet 100% of a job description’s criteria – maybe you’re feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us.Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation. We are an inclusive organization, and we welcome applications from a wide range of candidates. Selection for roles will be based on individual merit alone.**REFERRALS:** We love a good referral! If you know someone who would be a great fit for this position, please share!**APPLICATION DEADLINE:** The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.Make a move that matters. Join Tandem Diabetes Care, where we're turning challenges into triumphs every day and where your talents will help shape a healthier, happier tomorrow.#LI-BC1 #LI-Remote