Medical Device Quality Assurance and Regulatory Affairs Specialist

Há 5 dias

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$1.044.000 - R$1.194.000
Role Overview

Job Summary:

This individual will play a key role in implementing and maintaining local quality and regulatory strategies to ensure compliance with regulatory requirements.

Key Responsibilities:

  • Develop and maintain QMS procedures that address local regulatory requirements and Global Align policies.
  • Ensure that the corporate RA is kept up-to-date on new regulations, submissions dates, and local approvals.
  • Obtain and maintain regulatory product registrations as required.
  • Act as the focal point for document collection of RA registration processes.
  • Facilitate communication between the factory and certification bodies, as well as relevant stakeholders.
  • Support QMS activities, including management reviews, internal/suppliers audits, and CAPA's.
  • Prepare registration dossiers and maintain Regulatory Affairs documentation updated and organized to support compliance with applicable regulatory requirements.
  • Manage electromedical product certificates, interacting with factories and INMETRO/ANATEL certification bodies.
  • Assist in planning and executing Certification audits.
  • Verify that required Align entity and suppliers regulatory licenses/permits have been obtained and are maintained accordingly.
  • Assist in the maintenance of sanitary and technical licenses.
  • Provide reports to Regulatory Authorities in accordance with current legislation (field actions, robberies).
  • Approve Advertising & Promotional materials distributed to local markets.

Requirements:

  • Minimum of 2 years experience in Quality Assurance and Regulatory Affairs with Medical Devices.
  • Knowledge of ANVISA regulatory requirements for medical devices, including product registration and good distribution practices from country scope.
  • Knowledge of Electromedical Certification process for Medical Devices.
  • Knowledge of Telecommunication Certification process for Medical Devices.
  • Ability to work cross-functionally with multiple projects, solving problems and communicating issues.
  • Ability to execute project/program tasks with general supervision and little guidance.
  • Bachelor's Degree in pharmacy, Odontology, Engineering, Business Administration or similar.
  • Advanced Microsoft Office skills, including Word, PowerPoint and Visio.
  • Advanced English language proficiency.
  • Basic Spanish language knowledge.

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