Sr Clinical Affairs Specialist

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: 

As the Senior Clinical Affairs Specialist, your role entails leading complex clinical tasks for both existing products and investigations. 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.

Main responsibilities:

Provide strategic guidance and oversight, mentoring junior staff and coordinating with senior management.

Keep updated the clinical evaluations documents following MDR and others applicable regulations according to corporate objectives.

Advanced clinical support, including document creation for product registration and statistical analysis of clinical trials.

Create, implement and administer methods and procedures to enhance operations, as appropriate.

Provide clinical feedback and knowledge to Regulatory Affairs in the creation of documents required for products registration and technical file (Clinical Evaluation Report).

Create and update literature review reports by conducting systematic and comprehensive searches of published clinical literature following internal procedures.

Clinical trials reports creation.

Submission package readiness for Ethics Committees approval; including clinical protocols, design case report forms, patient and investigator brochure, informed consent form, among others.

Verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification, collecting completed CRF forms.

Support and review of statistical plans for clinical trials

Job Requirements

Bachelor’s degree in health sciences.

Familiarity with ISO 14155 (Clinical investigation of medical devices)

Proficient with MS office tools (Word, Excel, PowerPoint).

Good Clinical Practices

Knowledge in Systematic literature search

Medical Device Regulation

Advanced English

5 years of experience in similar roles focusing on Clinical Investigation or Regulatory Affairs experience.

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.