REGULATORY AFFAIRS SYSTEMS SPECIALIST

40.000.000 - 80.000.000


Valued Team Member: We are glad you are exploring new opportunities within Zimmer Biomet! What You Can Expect Regulatory Affairs (RA) Specialist for systems team provides support for the maintenance and implementation of RA systems, with a focus on Regulatory Information Management System (RIMS) and Regulatory Distribution Controls through SAP Global Trade Services (GTS) software. This role requires experience in data analysis and data mining. How You'll Create Impact Support Business Unit RA activities including publishing, filing, establishment registrations, product listing with the FDA, etc. Create and maintain regulatory affairs registrations and licenses in RIMS/GTS distribution control systems for global product distribution. Manage RA blocks and releases. Generate and communicate GTS/distribution control reports promptly. Maintain records (objective evidence) per procedures. Maintain GTS/distribution control block tracker. Support User Acceptance Testing (UAT) for RIMS and GTS as needed. Collaborate with global RA teams and customer service to resolve GTS/distribution control issues. Conduct gap analysis on license master data, develop summaries using Excel and data analysis tools. Upload and troubleshoot RA data in RIMS and GTS systems. Apply data mining and modeling tools to provide insights and process improvements. Understand software validation, testing protocols, and medical device regulations. Understand distribution, logistics, and order flow from ERP systems to GTS. Train team members on data integrity tools and techniques. Assist in creating training materials and work instructions. Generate queries, metrics, and reports. Ensure compliance with RA Procedures and Work Instructions. Work effectively with cross-functional teams. What Makes You Stand Out Experience with global regulatory systems preferred. Experience with data mining tools and advanced Excel skills preferred. Strong communication, writing, and interpersonal skills. Excellent problem-solving and analytical skills. Ability to learn and apply regulations related to medical devices, biologics, drugs, and combination products. Knowledge of EU, EMEA, APAC, LATAM, or US regulations for medical products. Attention to detail, organized, and consistent work style. Proficiency in SAP modules, SAP GTS, ERP systems, Microsoft Office, Adobe Professional, and Excel for data analytics. Your Background English proficiency (B2 or C1) required. Bachelor’s degree (or equivalent), preferably in life sciences, engineering, or related fields. 3-5 years of experience in Regulatory Affairs, Engineering, Quality, or related fields. Ensure your resume is in English when applying, as applications in other languages cannot be considered. Travel Expectations EOE/M/F/Vet/Disability #J-18808-Ljbffr

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