QRA Product Specialist

Location: Chicago, Illinois Salary: competitive
Sector: Pharma & Biotech, Medical Devices, Digital Health Type: Contract

Description of Work: Latin America Quality Regulatory Affairs Specialist Essential Duties and Responsibilities:

  • Responsible for the coordination and support of Latin America product registration requests throughout the product lifecycle
  • Support regional and country colleagues to develop and implement global regulatory strategies
  • Coordinates and collects specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments, as necessary to support registration requirements
  • Collaborate with regional regulatory personnel on assessing and documenting the reginal impact of product changes on global product registrations and licenses.
  • Knowledgeable in Latin American regulations and is able to interpret and communicate regulatory changes to ensure the business is aware of opportunities, risks and issues
  • Demonstrates collaboration with their regulatory team, cross functional team members, and regulatory agency partners by building strong and effective working relationships
  • Responsible for coordinating the submission of Technovigilance reports in the region

Sthree US is acting as an Employment Business in relation to this vacancy.