Regulatory Postmarket Specialist

Intuitive; Mexicali; On-site; MXN 400,000 - 640,000; Full time

Job summary

Intuitive in Mexicali, Mexico, is seeking an experienced regulatory professional to support post-market strategies and reporting for its surgical devices. This onsite role collaborates with Regulatory Affairs, Quality, and Medical teams to ensure compliance with post-market requirements.

You will develop PMS Plans and PSURs, summarize data for clear dashboards, and help prepare regulatory submissions. Advanced English and STEM degree are required, with 5+ years in medical device regulation.

Qualifications

• Degree in engineering, life sciences, or STEM with at least 5 years of related experience.
• Advanced English proficiency, both written and spoken.
• Knowledge of data analysis and technical writing.
• Understanding regulatory reporting requirements for Medical Devices (FDA, EU MDR).

Responsibilities

• Develop post-market strategies, plans, and reports for new and existing products.
• Collaborate with cross-functional teams to create PMS Plans and PSURs.
• Partner with Regulatory Affairs, Quality, Risk Management, Medical Science, Clinical Affairs, and Medical Affairs.
• Develop regulatory post-market documentation (PMS Reports, PSURs).
• Summarize data and present reports clearly for readability and quality improvement.
• Build relationships with stakeholders across Regulatory, Post Market Surveillance, QA, Risk, Medical Science, and Medical Affairs.
• Apply EU MDR regulations to guide post-market requirements.
• Demonstrate good judgment for solutions and drive results with some supervision.
• Lead meetings and use tools (Zoom, Box, SharePoint) and develop dashboards.
• Draft and assemble documentation for internal records and regulatory submissions.
• File documentation in systems such as Agile.
• Participate in process improvement activities to enhance effectiveness.
• Execute on projects as directed by Manager or Director of Post Market.

Skills

Advanced English proficiency

Data analysis

Technical writing

Regulatory reporting knowledge

Education

STEM degree (engineering, life sciences, or equivalent)

Job description

• Ways of Working: Onsite - This job is fully onsite.
• Employee Type: Employee
• Global Job Level (HCM): Professional 3 (9)

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.

• 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
• Advanced English proficiency, both written and spoken.

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.