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 RA Specialist participates in the execution of technical regulatory activities according to corresponding product/project needs to ensure product and business compliance with relevant national and international regulatory requirements and in accordance with the Quality Management System. Main responsibilities:
Provides regulatory compliance guidance as early input to the development of new products or product changes.
Responsible for labeling development and review for new products or product changes.
Supports the development of regulatory strategies for new products development or product introductions.
Creates and edits technical files and regulatory documents for medical devices.
Oversees that new product technical documentation meets the regulatory guidance provided.
May conduct internal audits according to ISO 13485 and support regulatory inspections.
Support the Standards and Regulations Gap Assessment process.
Job Requirements:
University Degree in applied science or other related area or equivalent experience.
Knowledge of ISO, FDA, CE Mark, Risk Management and other quality standards and regulations applicable to medical devices.
Computer literacy is required, knowledge of commercial software package (i.e. Windows or similar) and basic computer configuration.
Intermediate English
4 - 5 year of experience working in regulated industry (medical devices, pharma)
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.