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Regulatory Post Market Surveillance Analyst

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:
 
The Regulatory Post Market Surveillance Analyst investigates customer complaints, makes initial reporting decisions, files regulatory reports, and ensures completeness and consistency of complaint documentation.

Roles and Responsibilities:

This position has responsibility and authority for:

  • Investigating complaints daily:
    • Perform the preliminary classification of complaints and escalate complaints that require additional review.
    • Perform Failure Analysis investigation review and escalate complaints that require additional review.
    • File Malfunction MDR Reports as identified
    • Escalate Adverse Event or Incident reports to Level IV Analysts as identified
    • 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.
    • Review and analyze lot documentation (DHRs) to determine if there are any anomalies that maybe related to reported product failures.
  • Escalate complaints to the Regulatory Post Market Surveillance Manager or Lead when new failure modes are encountered.

Escalate complaints with potential related product failures to the Post Market Investigation (PMI) group

  • Evaluate complaints for reporting requirements in accordance with company procedures and Regulatory requirements.
  • Interface with Customer Service and hospitals to gather additional information required for complaint investigation, including retrieval of RMA
  • Create customer response letters upon request
  • Provide peer review and feedback of complaints and reports
  • Participate in new hire training and continuous Regulatory Compliance training as required
  • Participate in process improvement activities to continuously improve process effectiveness
  • Execute on projects as required
  • Perform other duties as directed

Qualifications

Education - degree in engineering, life science, or equivalent

Experience – 4+ years of experience in medical device field, with experience in the following areas:

      • Working knowledge and understanding with Medical Device Complaint files and quality record documentation
      • Working knowledge and understanding of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements, etc.).

Skills: The following skills are required for this position:

  • Demonstrate strong written and verbal communication skills
  • Strong computer skills (Excel, Word, PowerPoint, database)
  • Efficient independent worker with ability to focus
  • Attention to detail
  • 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
  • Contribute to team-oriented tasks
  • Strong analytical skills
  • Strong interpersonal and decision-making skills.

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

  • Firm understanding of Regulatory reporting requirements for Medical Devices and complaint system and process requirements.
  • Firm understanding of quality records requirements and how they apply to complaint files.
  • Familiarity with world-wide regulatory reporting requirements.
  • Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary..

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

The Future is Intuitive

At Intuitive, we envision a future where care is more connected, customized, and intelligent—so the question won’t just be how long we live, but how well.

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