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

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 technical support for regulatory submissions, product registrations, certifications, and responses to regulatory authorities.

Support the planning, execution, and oversight of clinical investigations, including preparation of study documentation and Ethics Committee submission packages.

Review clinical study documents, reports, literature evaluations, and clinical data analyses to ensure quality, consistency, and scientific validity.

Monitor clinical data quality and study conduct, identify potential compliance issues, and support audit and oversight activities.

Serve as the Clinical Affairs subject matter expert for Regulatory Affairs, Research & Development, Post-Market Surveillance, Design Quality Assurance, Medical Affairs, Commercial teams, and other stakeholders.

Support risk management activities by providing clinical input and ensuring alignment between clinical evidence and product safety requirements.

Mentor and provide technical guidance to junior Clinical Affairs team members, supporting professional development and high-quality deliverables.

Identify opportunities for process improvements and contribute to the enhancement of Clinical Affairs procedures, systems, and best practices.

Maintain current knowledge of applicable regulations, clinical standards, scientific literature, and industry trends to ensure ongoing compliance and regulatory readiness.

Requirements

Bachelor's degree in Health Sciences, Life Sciences, Nursing, Pharmacy, Medicine, Biomedical Engineering, or a related field.

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

Strong knowledge of international medical device regulations and standards, including Good Clinical Practices (GCP), and ISO 14155 .

Experience conducting systematic literature reviews and evaluating clinical data and scientific evidence.

Knowledge of risk management principles and their application within medical device development and lifecycle management.

Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

Strong written and verbal communication skills in Spanish and English (intermediate to advanced English required).

Availability to travel as required.

Valid U.S. visa and Yellow Fever vaccination are considered desirable but are not mandatory.

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.