About Us:

Establishment Labs is changing the medical device, breast health, aesthetics and reconstruction industry by designing, developing, and manufacturing an innovative portfolio of advanced medical aesthetic device technologies and wellness solutions. It is currently the world’s fastest-growing women’s health company.

Our Femtech solutions are proudly produced at two MDSAP-certified, carbon neutral, LEED Gold certified, state-of-the-art manufacturing facilities in Costa Rica and are approved for sale in more than 85 countries.

Since 2018 the company trades on the NASDAQ stock exchange under the ticker symbol ESTA and has a market cap of around $1.8 billion.

This is an exciting opportunity to join an innovative international company in hyper-growth as we launch a significant revolution to transform the women´s aesthetics industry.

Objective

The Clinical Research Associate (CRA) is responsible for overseeing all aspects of the study lifecycle, including study design, implementation, site qualification, site initiation, and ongoing monitoring.



This role ensures that clinical investigations and Post Market Clinical follow up studies in the United States and internationally are conducted in full compliance with regulatory and quality requirements.

Main Responsibilities

Prepare documents required for IRB’s/Ethical Committees submission. This includes developing and writing clinical trial protocols, design Case Report Forms, Patient and Investigator Brochure, Informed Consent Form, etc.
Assist and review interim and annual study reports and response for FDA.
Communicate with Investigative Sites and consultants on conducting clinical trials.
Data compilation, ensuring quality control and compliance with protocol and provide initial analysis of results.
Monitor clinical trial progress through a combination of data review and on-site monitoring visits.
Conduct site visits for pre-qualification, qualification, initiation, monitoring and close-out.
Verify that data

📌 Clinical Research Associate (Ciudad de México)
🏢 Establishment Labs
📍 Ciudad de México