Regulatory Affairs Systems Specialist

hace 1 semana


Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completo
About This Role

Zimmer Biomet is a global medical technology leader, dedicated to enhancing patient mobility and quality of life. As a key member of our team, you will play a critical role in supporting our mission by ensuring compliance with regulatory requirements for our medical devices.

Key Responsibilities
  • Support the maintenance and implementation of regulatory systems, with a focus on Regulatory Information Management System (RIMS) and Regulatory Distribution Controls through SAP Global Trade Services (GTS) software.
  • Provide data analysis and data mining support to ensure accurate and timely regulatory submissions.
  • Collaborate with global regulatory teams and customer service to resolve issues related to GTS/distribution control blocks and maintenance of objective evidence.
  • Conduct gap analysis on existing license master data and develop summaries using advanced Excel and other data analysis tools.
  • Upload and maintain RA data in RIMS and GTS system using automated upload tools and troubleshoot data errors as needed.
  • Apply technical expertise in data mining and modeling tools to provide insights into distribution control data for RA and suggest appropriate measures for enhancement of existing processes.
  • Support the creation of training materials and work instructions for team members.
Requirements
  • Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred.
  • English Proficiency is required (C1). Portuguese is preferred.
  • A minimum of 3-5 years of experience in Regulatory Affairs, Engineering, Quality, or related field required.
What We Offer

Zimmer Biomet is committed to creating an environment where every team member feels inspired, invested, cared for, valued, and has a strong sense of belonging. We offer a competitive total rewards package, wellness incentives, and a culture of recognition and performance awards.



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