Company Description
It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.
We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.
The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.
If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.
Job Description
Primary Function of Position
The Regulatory Post Market Surveillance Specialist investigates customer complaints, makes an initial reporting decision, provides failure analysis letters, and ensures completeness and consistency of complaint and related documentation.
Essential Job Duties
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 to the Post Market Investigation (PMI) group as required
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
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
Qualifications
Required Education and Training
Education - degree in engineering, life science, or equivalent
English proficiency required: 85% (spoken and written).
Experience – 2+ years of experience in medical device field, with experience or exposure in the following areas:
Knowledge and understanding with Medical Device Complaint files and quality record documentation
Knowledge and understanding of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements, etc.)
General technical and or clinical medical device knowledge
Working Conditions
None
Preferred Skills and Experience
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
General understanding of Regulatory reporting requirements for Medical Devices and complaint system and process requirements
General understanding of quality records requirements and how they apply to complaint files
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.
Aviso sobre los Controles de Exportación de EE. UU.: De acuerdo con las Regulaciones de Administración de Exportaciones de EE. UU. (15 CFR §743.13(b)), algunos puestos en Intuitive Surgical pueden estar sujetos a controles de exportación de EE. UU. para candidatos que sean nacionales de países actualmente bajo embargo o sanciones.
Cierta información que usted proporcione como parte de la solicitud será utilizada para determinar si Intuitive Surgical necesitará (i) obtener una licencia de exportación del gobierno de EE. UU. en su nombre (nota: el proceso de obtención de la licencia puede tardar entre 3 y más de 6 meses) o (ii) implementar un Plan de Control de Tecnología (“TCP”, por sus siglas en inglés) (nota: normalmente este paso agrega 2 semanas al proceso de contratación).
Para cualquier puesto en Intuitive sujeto a controles de exportación, las ofertas finales están condicionadas a la obtención de una licencia de exportación aprobada y/o a la ejecución de un TCP antes de la fecha de inicio del empleado potencial, la cual puede o no ser flexible, y dentro de un plazo que no obstaculice de manera irrazonable la necesidad de contratación. Si aplica, los candidatos serán notificados e instruidos sobre cualquier requisito relacionado con estos fines.
Este puesto puede cubrirse con un nivel de puesto diferente al indicado aquí, según las necesidades del negocio y/o la experiencia, los conocimientos y las habilidades del candidato o la candidata seleccionado. La compensación se basará principalmente en el nivel del puesto en el que se cubra el rol y en las cualificaciones del candidato o la candidata, de conformidad con la legislación aplicable.
Shift: Day
