What You Will Do
We are seeking a Regulatory Affairs Analyst responsible for preparing and maintaining regulatory documentation for the registration and compliance of medical devices with ANVISA. This professional will manage product licenses, support new product launches, oversee electromedical certifications, and ensure all internal regulatory controls are up to date. The role requires strong collaboration with manufacturing sites, certification bodies, and internal teams, as well as a solid understanding of Brazilian regulatory frameworks. The ideal candidate will be highly organized, analytical, and capable of communicating effectively with external authorities and internal stakeholders.
Key Responsibilities:
- Prepare and review technical and regulatory documentation for medical device registrations with ANVISA, including initial submissions, renewals, and updates.
- Ensure compliance with all applicable regulatory standards, including RDC 185/01, related regulations, FCPA, and Stryker’s Code of Conduct.
- Maintain up-to-date records of product registrations to support legal importation and commercialization of medical devices in Brazil.
- Execute registration strategies for new product launches, ensuring timely submissions aligned with launch plans.
- Manage electromedical certification processes, coordinating with manufacturing sites and certification bodies to ensure product compliance.
- Keep all internal tracking systems and regulatory controls current, including submission status and documentation timelines.
- Support Sales and Marketing teams by providing product regulatory information and executing item registration in the company’s internal systems.
- Represent the company in interactions with regulatory agencies, clients, and public authorities, upholding professionalism, technical expertise, and ethical standards in all communications.
What you need:
Required:
- Bachelor’s degree
- Experience with Microsoft Office Suite
- Previous experience in the medical devices industry
- Experience with INMETRO and ANATEL certifications
- Solid knowledge of Ordinance 384/2020 and IN 283/2024
- Familiarity with regulatory frameworks: RDC 751/2022, RDC 848/2024, and RDC 579/2021
Preferred:
- Advanced Spanish level
- Knowledge of Quality Standard 665/2022