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Regulatory Affairs Systems Specialist
hace 3 meses
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.
What You Can Expect
Regulatory Affairs (RA) Specialist for systems team provides support for the maintenance and implementation of RA systems, with particular focus on Regulatory Information Management System (RIMS) and Regulatory Distribution Controls through SAP Global Trade Services (GTS) software. This position requires experience with 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 in support of regulatory controls for global product distribution. Release and management of RA blocks. Generate and communicate GTS/distribution control reports in a timely fashion. Maintain records (objective evidence) per established procedures. Maintain GTS/distribution control block tracker. Perform and support User Acceptance Testing (UAT) as needed for RIMS and GTS. Work closely with global RA teams and customer service to resolve issues related to GTS/distribution control blocks and maintenance of objective evidence. Conduct appropriate gap analysis on the 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. Ability to 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. This position requires a level of understanding of software validation and testing protocols. This position requires an understanding of medical devices regulations and their use. Understanding of 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.
What Makes You Stand Out
Preferred experience with global regulatory systems. Preferred experience/projects related to data mining tools and advanced Excel skills. Strong writing, communication, and interpersonal skills. Strong problem-solving and analytical skills. Ability to learn and apply regulations pertinent to medical devices, biologics, drugs and combination products, specific to functional work team. Knowledge of EU, EMEA, APAC, LATAM, or US regulations pertinent to medical devices, biologics, drugs and combination products Attention to detail and capable of working in an organized and consistent manner. Software Skills- SAP modules, SAP GTS, ERP systems, Microsoft Office Suite, Adobe Professional and Excel for data analytics
Your Background
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.Please note that you must submit your resume in English at the time of applying, or your application will not be considered.
Travel Expectations
EOE/M/F/Vet/Disability
