Postmarket Regulatory Specialist - Data-Driven Impact

Intuitive; Mexicali; Sur place; MXN 400 000 - 640 000; Plein temps

Résumé du poste

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).

Responsabilités

• 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.

Connaissances

Advanced English proficiency

Data analysis

Technical writing

Regulatory reporting knowledge

Formation

STEM degree (engineering, life sciences, or equivalent)

Description du poste

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.