Regulatory Affairs Systems Analyst

hace 2 semanas

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

At Zimmer Biomet, we are dedicated to advancing innovation and fulfilling our mission. As a leading global medical technology company for nearly a century, our products enhance patient mobility every 8 seconds.

As a member of the Zimmer Biomet team, you will contribute to our mission of providing mobility and renewed life to individuals worldwide. We prioritize development opportunities, robust employee resource groups (ERGs), a flexible work environment, competitive rewards tailored to specific locations, wellness incentives, and a culture that recognizes and rewards performance. We strive to create an atmosphere where every team member feels inspired, valued, and has a strong sense of belonging.

Role Overview

The Regulatory Affairs (RA) Specialist for the systems team is responsible for supporting the maintenance and implementation of RA systems, with a particular emphasis on the Regulatory Information Management System (RIMS) and Regulatory Distribution Controls via SAP Global Trade Services (GTS) software. This role necessitates experience in data analysis and data mining.

Key Responsibilities
  • Assist Business Unit RA activities including publishing, filing, and product listings with regulatory authorities.
  • Establish and maintain regulatory affairs registrations and licenses within RIMS/GTS distribution control systems to support global product distribution.
  • Manage the release and oversight of RA blocks.
  • Generate and disseminate GTS/distribution control reports promptly.
  • Maintain comprehensive records in accordance with established procedures.
  • Oversee the GTS/distribution control block tracker.
  • Conduct User Acceptance Testing (UAT) for RIMS and GTS as required.
  • Collaborate with global RA teams and customer service to address issues related to GTS/distribution control blocks.
  • Perform gap analysis on existing license master data and create summaries using advanced Excel and other analytical tools.
  • Upload and manage RA data in RIMS and GTS systems using automated tools and troubleshoot data discrepancies.
  • Utilize technical expertise in data mining and modeling tools to derive insights from distribution control data and recommend process enhancements.
  • Understand software validation and testing protocols.
  • Comprehend medical device regulations and their applications.
  • Grasp distribution, logistics, and order flow from various Enterprise Resource Planning (ERP) Systems to GTS.
  • Provide training to team members on data integrity maintenance tools and techniques.
  • Assist in the development of training materials and work instructions.
Qualifications
  • Preferred experience with global regulatory systems.
  • Experience with data mining tools and advanced Excel skills is advantageous.
  • Strong writing, communication, and interpersonal abilities.
  • Excellent problem-solving and analytical skills.
  • Capacity to learn and apply regulations relevant to medical devices, biologics, drugs, and combination products.
  • Knowledge of EU, EMEA, APAC, LATAM, or US regulations applicable to medical devices, biologics, drugs, and combination products.
  • Attention to detail and ability to work in an organized and consistent manner.
  • Proficiency in SAP modules, SAP GTS, ERP systems, Microsoft Office Suite, Adobe Professional, and Excel for data analytics.
Educational Background
  • Bachelor's degree (or non-US equivalent) required; a concentration in life sciences, technical/engineering, or a related field is preferred.
  • Proficiency in English is required (C1); proficiency in Portuguese is preferred.
  • A minimum of 3-5 years of experience in Regulatory Affairs, Engineering, Quality, or a related field is required.
Travel Expectations

EOE/M/F/Vet/Disability

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