Regulatory Affairs Manager, LATAM & Brazil Responsável Técnico

Position Overview

We are seeking a LATAM Regulatory Affairs Manager & Brazil Responsável Técnico (RT) to lead the regulatory roadmap across Latin America. The role serves as the primary bridge between Global Headquarters and local markets, driving efficient market access for Class III/IV surgical devices, and acts as the legally designated RT for the Brazil subsidiary with responsibility for quality compliance and legal accountability.

Key Responsibilities

Regional Strategic Leadership (LATAM)

• Market Access Roadmap: Develop and execute regulatory registration strategies for key markets, including Brazil (ANVISA), Colombia (INVIMA), Mexico (COFEPRIS), Argentina (ANMAT), and Chile (ISP).
• Regulatory Reliance: Leverage Brazil’s IN 290/2024 and similar reliance pathways in Colombia and Mexico to accelerate approvals using FDA, PMDA, or EU MDR data.
• Distributor Oversight: Audit and manage third‑party distr...