Regulatory Postmarket Specialist

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  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,…