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Regulatory Post Market Surveillance Manager

Company Description

Descripción de la empresa

En Intuitive, estamos unidos detrás de nuestra misión: creemos que la atención mínimamente invasiva es la atención que mejora la vida. Mediante la inventiva y la tecnología inteligente, ampliamos el potencial de los médicos para curar sin limitaciones.

Como pioneros y líderes del mercado en cirugía robótica, nos esforzamos por fomentar un equipo inclusivo y diverso, comprometido con marcar la diferencia. Durante más de 25 años, hemos trabajado con hospitales y equipos de atención de todo el mundo para ayudar a resolver algunos de los desafíos más difíciles de la atención médica y avanzar en lo que es posible.

Intuitive se ha construido gracias a los esfuerzos de grandes personas de diversos orígenes. Creemos que las grandes ideas pueden provenir de cualquier lugar: nos esforzamos por fomentar una cultura inclusiva basada en la diversidad de pensamientos y en el respeto mutuo. Lideramos con inclusión y capacitamos a los miembros de nuestro equipo para que trabajen de la mejor manera y manifiesten su auténtica personalidad.

Las personas apasionadas que quieren marcar la diferencia impulsan nuestra cultura: los miembros de nuestro equipo se basan en la integridad, tienen una sólida capacidad para aprender, la energía para hacer las cosas, y aportan experiencias diversas del mundo real para ayudarnos a pensar de nuevas maneras. Invertimos activamente en los miembros de nuestro equipo para apoyar su crecimiento a largo plazo y así poder continuar avanzando en nuestra misión y alcanzar su máximo potencial.

Únase a un equipo comprometido a dar grandes pasos hacia delante para una comunidad global de profesionales de atención médica y sus pacientes. Juntos, avancemos en el mundo de la atención mínimamente invasiva.

Job Description

Primary Function of Position:
 
Reporting to the Senior Manager of the Post Market Surveillance department, the Post Market Surveillance Manager will coordinate and supervise the day to day activities of the complaint investigation team. The Manager will provide guidance, instruction and feedback to the group as needed and ensure completeness, accuracy and consistency and compliance of complaint documentation and regulatory reporting decisions.

In addition, this management position will collaborate with other leaders within the post market team identify and implement procedure and process improvements.  The position will also have the responsibility to provide analysts with opportunities for continuous learning, professional development and growth plans. As the team will continue to grow to support the business, the management role will need to constantly identify tools, training and any other items that will improve their team’s overall effectiveness, efficiency and, ultimately, success.


Roles and Responsibilities:

This position has responsibility and authority for:

  • Day to day management of the complaint investigation team within the Regulatory Post Market Surveillance department
  • Collaboration with internal teams including customer service, field engineering, technical support, engineering, clinical development and other departments as needed
  • Ensure working compliance to processes and procedures
  • Write, review, and file Medical Device Reports (MDRs) and Vigilance Reports
  • Prepare responses to Regulatory agency requests for additional information
  • Represent Regulatory Compliance at selected cross functional meetings
  • Investigating complaints:
    • Perform classification of complaints and escalate complaints that require additional review.
    • Perform Failure Analysis investigation review and escalate complaints that require additional review.
    • File Regulatory Reports as identified and required (including Adverse Event and Incident related reports)
    • Evaluate documentation for completeness and consistency, and assign additional actions as necessary to close the complaint file.
    • Approve final complaint file for closure after all applicable actions are completed.
    • Manage complaint workload to required backlog goals
  • Escalate complaints to the Quality group or other designated teams when new failure modes are encountered.
  • Evaluate complaints for reporting requirements in accordance with company procedures and Regulatory requirements.
  • Create and / or review customer response letters
  • Provide review and feedback of complaints and reports to analysts
  • Participate in process improvement activities to continuously improve process effectiveness, efficiency and compliance
  • Assist in the organization and provision of complaint data for the Product Inquiry Report process.
  • Analyze and trend complaint data to identify new issues or systemic discrepancies as necessary. 
  • Participate in new hire training and continuous Regulatory Compliance training as required
  • Execute on projects as required
  • Perform other duties as directed

Qualifications

Skill/Job Requirements:
Education =  Undergraduate degree in engineering, life science, or equivalent

Experience =  5+ years of experience in employee management in the medical device field, with specific experience in the following areas:

    • Management experience in a dynamic fast paced environment
    • Working experience in a Regulatory management role
    • Strong working knowledge of Medical Device Complaint files and quality record documentation requirements and implementation
    • Strong working knowledge of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements, PMDA Japan, etc.)

Skills: The following skills are required for this position:

    • Exhibit strong leadership skills
    • Demonstrate strong written and verbal communication skills
    • Efficient independent worker with ability to focus
    • Attention to detail
    • Ability to lead meetings or cross functional teams to come to resolution
    • Demonstrate cross functional communication skills in email and in person
    • Excellent organizational and analytical skills
    • Ability to handle and manage workload independently
    • Prioritize numerous activities in a rapid paced environment
    • Strong computer skills (Excel, Word, PowerPoint, database)
    • Contribute to team oriented tasks

Competency / Training: The following competencies are essential for this position:

    • Strong understanding of Regulatory reporting requirements for Medical Devices and complaint system and process requirements.
    • Strong understanding of quality records requirements and how they apply to complaint files.
    • Working experience with world-wide regulatory reporting requirements.

Additional Information

Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados, y prohibimos cualquier tipo de discriminación y acoso, independientemente de su raza, sexo, condición de embarazo, orientación sexual, identidad de género, origen nacional, color, edad, religión, condición de veterano protegido o de discapacidad, información genética o cualquier otra condición protegida por las leyes federales, estatales o locales aplicables.

Shift: Day
Travel: 10% of the time

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