Senior Regulatory Compliance Expert

1 dia atrás


São Paulo, São Paulo, Brasil beBeeSpecialist Tempo inteiro R$115.880 - R$193.491
Regulatory Affairs Specialist Position

This position entails coordinating and ensuring the proper submission and approval of various medical devices or other categories of products to government regulatory agencies.

Main Responsibilities:
  • The Regulatory Affairs Specialist will be responsible for overseeing the work of RA Specialists to ensure timely submissions
  • Selecting and managing external consulting services to prepare files in same conditions as internal teams
  • Supporting regional teams on product submissions, prioritization, and pipeline management
  • Serving as liaison for franchises to support business plans and regulatory needs
  • Leading training sessions for RA Specialists
  • Developing innovative strategies/solutions for technical files and submission to fulfill requirements and be in compliance with regulatory agency requirements
  • Participating in multifunctional teams to establish regulatory strategic plans
  • Assisting in the development and implementation of regulatory strategies with team representatives and the Regulatory Affairs Manager
Requirements:
  • At least 4 years of experience working in a Regulatory Environment
  • Preparing submissions for complex devices and a successful track record
  • Desirable experience in Medical Devices, Pharma background acceptable
  • Bachelor's Degree in Engineering, Pharmacy, or other life science
  • Experience with people management desirable
  • Knowledge of Local & International Regulation and Processes
  • Bi-lingual: Fluent English - local language (Portuguese)

This is an opportunity to join our organization as a key member of the Regulatory Affairs team. As a Regulatory Affairs Specialist, you will play a critical role in ensuring that our products meet regulatory requirements and are approved for market release.



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