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 Affairs Senior Specialist provides advanced clinical and technical expertise to support clinical affairs activities for both marketed and new medical devices. You're responsible for crafting, reviewing,



and updating clinical documents per regulations, while offering strategic direction. Your collaboration extends across various company departments, including Medical Affairs and Regulatory Affairs, to ensure compliance with industry standards. Additionally, you serve as a mentor to less experienced team members, engage with upper management, and work with clinical research staff and investigators. Extensive experience in clinical affairs and a solid background in managing projects are critical for success.

Key Responsibilities

Lead the preparation, review, and maintenance of clinical and technical documentation, including Clinical Evaluation Reports (CERs), PMCF Plans and Reports, SSCPs, and related clinical documents.
Ensure clinical documentation complies with applicable regulations, standards, and guidance, including EU MDR, ISO 14155, GCP, MEDDEV guidance, and internal procedures.
Provide clinical and t

📌 Sr. Clinical Affairs Specialist (Ciudad de México)
🏢 Establishment Labs
📍 Ciudad de México