As a Regulatory Affairs Specialist for systems team, you provide 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 Create Impact

• Create and maintain regulatory affairs registrations and licenses in RIMS/GTS distribution control systems in support of regulatory controls for global product distribution.
• Generate and communicate distribution control reports in a timely fashion.
• Maintain records (objective evidence) per established procedures.
• 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.
• 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.
• Conduct training for the team members on tools and techniques for maintaining data integrity.
• Support the creation of training materials and work instructions.
• Support the generation of queries, metrics and reports.
• Maintain compliance with RA Procedures and Work Instructions.

What Will Make You Stand Out

You hold a bachelor’s degree in science or engineering, an advanced degree is a plus.

In addition you have at least 3 to 5 years of experience in data analysis and data mining, ideally in a multicultural environment related to Regulatory Affairs, Engineering or Quality. An experience with global regulatory systems is preferred.

You have developed strong skills such as:

• Understanding of software validation and testing protocols.
• Understanding of distribution, logistics and order flow from various Enterprise Resource Planning (ERP) Systems used by the company to GTS.
• Software Skills- SAP modules, SAP GTS, ERP systems, Microsoft Office Suite, Adobe Professional and Excel for data analytics
• Knowledge of EU, EMEA, or US regulations pertinent to medical devices, biologics, drugs and combination products
• English Proficiency is required; knowledge of additional EU languages is preferred.

What Will Make You Successful

• Strong writing, communication, and interpersonal skills.
• Strong problem-solving and analytical skills.
• Attention to detail and capable of working in an organized and consistent manner.
• Ability to work with cross-functional teams.