Regulatory Postmarket Specialist

Mexicali, MEXICO, Mexico

Not Remote

Quality & Regulatory

JOB216245

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

This role provides expertise and support for developing post-market strategies, plans, and reports for new and existing products. Collaborates with cross-functional teams to create documentation such as PMS Plans and Periodic Safety Update Reports (PSURs) that support regulatory approvals and ensure compliance. Partners closely with Regulatory Affairs, Quality, Risk Management, Medical Science, Clinical Affairs, and Medical Affairs.

Essential Job Duties

Support the development of strategies that meet regulatory post-market requirements in collaboration with cross-functional teams.

Create regulatory post-market documentation such as PMS Reports and PSURs.

Summarize data and use methods of data presentation that improve the quality and readability of reports and documentation.

Build relationships with key stakeholders and cross-functional partners including Regulatory Affairs, Post Market Surveillance, Quality Assurance, Risk Management, Medical Science, Clinical Affairs and Medical Affairs.

Apply working knowledge of regulations like European Union Medical Device Regulation (MDR) to guide project teams through the regulatory post market requirements.

Demonstrate good judgement for obtaining solutions.

Work to manage priorities and drive results with some supervision.

Facilitate effective team collaboration by leading meetings, using software tools (e.g. Zoom, Box, SharePoint), and developing dashboards and other communication tools.

Draft and assemble documentation as required for internal

records and regulatory submissions.

File documentation in systems such as Agile.

Participate in process improvement activities to continuously improve process effectiveness.

Execute on projects as required by Manager or Director of Post Market.

Qualifications

Required Experience and Education

Degree in engineering, life science, or equivalent (S.T.E.M.) with minimum of 5 years of related experience with a University degree; or 3 years’ experience and a Master’s degree; or a PhD without experience; or equivalent work experience.

English 90%

Required Knowledge, Skills and Abilities

Knowledge of data analysis and technical writing.

Understanding of Medical Device Complaint files and quality record documentation.

Understanding or experience of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDR requirements, etc.).

Working technical and clinical medical device knowledge.

Additional Information

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