Regulatory Affairs Systems Specialist
hace 1 semana
Zimmer Biomet is a global medical technology leader with a commitment to innovation and driving our mission forward. As a team member, you will be part of a talented group that shares our commitment to providing mobility and renewed life to people around the world.
Key Responsibilities- Support Business Unit Regulatory Affairs activities, including publishing, filing, establishment registrations, and product listing with the FDA.
- Create and maintain regulatory affairs registrations and licenses in RIMS/GTS distribution control systems in support of regulatory controls for global product distribution.
- Release and manage RA blocks, generate and communicate GTS/distribution control reports in a timely fashion, and maintain records per established procedures.
- Maintain GTS/distribution control block tracker, perform and support User Acceptance Testing (UAT) as needed for RIMS and GTS, and work closely with global RA 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, develop summaries using advanced Excel and other data analysis tools, and 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.
- Understand software validation and testing protocols, medical devices regulations, and their use, as well as distribution, logistics, and order flow from various Enterprise Resource Planning (ERP) Systems used by the company to GTS.
- Conduct training for the team members on tools and techniques for maintaining data integrity, support the creation of training materials and work instructions, and have a strong understanding of EU, EMEA, APAC, LATAM, or US regulations pertinent to medical devices, biologics, drugs, and combination products.
- English Proficiency is required (C1), and Portuguese is preferred.
- Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred.
- A minimum of 3-5 years of experience in Regulatory Affairs, Engineering, Quality, or related field required.
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