Regulatory Affairs Manager, Global Registrations

• 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: 

This is one of the roles of Regulatory Affairs Manager which specifically supervises and coordinates the required regulatory activities to support the business market growth strategies through product approvals and/or registrations in accordance with commercial needs and opportunities. 

This role will have access to confidential and sensitive information that must be handled accordingly, therefore trustful and ethic behaviors are expected to execute this position; good interpersonal and communication skills are required since this role will have close interaction with internal departments and may be considered a Subject Matter Expert (SME). 

Main responsibilities:

• Leads the corporate regulatory registration and registration renewals process.
• Leads the Regulatory registration team to balance workload distribution among the team members and support career development.
• Oversee the preparation and submission of registration documentation necessary to obtain market approvals for products in all regions.
• Maintain and control product regulatory status worldwide via the Product Safety Net.
• Oversee the activities required for regulatory compliance at the different regulatory data bases (FDA GUDID, EUDAMED, GDSN Center, etc.) 
• Reviews, creates, and edits technical files and regulatory documents for medical devices.
• Participates in area improvements as part of the Quality Management System.  
• Support regulatory inspections.
• Support the  Regulations Gap Assessment process. 
• Supports the QMS Change Control review process from the regulatory perspective. 
• Leads responses to regulatory entities regarding questions that may come up from the regulatory review and submissions. 
• Reports out on status of regulatory processes or regulatory requirements. 
• May fulfilled the Regulatory Affairs role in certain QMS processes and documents. 

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
• Advanced English
• Proficiency in other languages is a plus (French, Portuguese, others).
• Experience in a regulated industry.
• Experience working in the Regulatory Affairs areas.
• Highly developed soft skills and the ability to communicate effectively both verbally and in writing, with diverse audiences.
• 5-10 years’ experience in a regulated industry (e.g., medical devices, pharmaceutical). 
• 2 or more years of experience working in the Regulatory Affairs areas.
• 2 years in personnel supervisor role, at least 1 year as a manager. 
  

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.