Postmarket Regulatory Specialist – Data & Reporting

Intuitive; México; On-site; MXN 700,000 - 1,000,000; Full time

Job summary

Intuitive Surgical in Mexico is seeking an experienced regulatory post-market specialist to develop and manage post-market strategies, PMS plans, and PSURs for medical devices.

You will collaborate with Regulatory Affairs, Quality, Risk Management, Medical Science, Clinical Affairs and Medical Affairs to ensure compliance with US FDA and EU MDR requirements, while advancing data-driven documentation and cross-functional teamwork.

Qualifications

• Degree in engineering, life science, or STEM with at least 5 years of related experience.
• Advanced English proficiency, both written and spoken.

Responsibilities

• Develop post-market strategies, plans, and reports for products.
• Create PMS Reports and PSURs for regulatory support.
• Summarize data and improve readability of reports and documentation.
• Build relationships with Regulatory Affairs, Post Market Surveillance, Quality Assurance, Risk Management, Medical Science, Clinical Affairs and Medical Affairs.
• Apply EU MDR and other regulatory requirements to guide post-market projects.
• Lead meetings and develop dashboards and communication tools.

Skills

Data analysis

Technical writing

Regulatory reporting

Medical device knowledge

English proficiency

Education

S.T.E.M. degree in engineering or life sciences

Job description

Intuitive Surgical in Mexico is seeking an experienced regulatory post-market specialist to develop and manage post-market strategies, PMS plans, and PSURs for medical devices.

You will collaborate with Regulatory Affairs, Quality, Risk Management, Medical Science, Clinical Affairs and Medical Affairs to ensure compliance with US FDA and EU MDR requirements, while advancing data-driven documentation and cross-functional teamwork.