PMS Device tracking Technician

hace 7 días

Alajuela, Alajuela, Costa Rica Establishment Labs A tiempo completo

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 Post-Market Surveillance Device Tracking Technician will provide technical support for device tracking, ensuring complete, accurate, and timely traceability of Class III medical devices in compliance with FDA requirements and other applicable regulatory authorities. This role supports data entry, verification, and documentation and contributes to the integrity of post-market data to support patient safety and regulatory compliance.

Main responsibilities:

  • Support the company's device tracking system in accordance with Quality System procedures and policies, ensuring proper implementation and compliance with applicable regulatory requirements.
  • Perform data entry, verification, and reconciliation activities to maintain accurate and complete device traceability records.
  • Recommend methods and techniques to enhance the effectiveness and sustainability of the device-tracking program.
  • Support regulatory reporting activities and collaborate with Regulatory Affairs, Quality System, and US teams.

Requirements:

  • Professional degree completed or in progress (minimum 50% completed) in Engineering, STEM, or Health Sciences.
  • Minimum of 1 year of experience in the medical device industry.
  • Intermediate English proficiency (B1–B2).
  • Strong task-tracking, data analysis, and data management skills

Important Note: This job description includes the necessary aspects required to evaluate this job position. It should not be used as a comprehensive list of all responsibilities, skills or functions.

At Establishment Labs we're committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability (visible and not visible), gender, gender identity or expression, or veteran status. We strive to be a more equal opportunity workplace.

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