RA Specialist (CL708749)

Job Summary

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.

Principal Duties and Responsibilities

• 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.
• 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.
• Support the generation of queries, metrics and reports.
• Maintain compliance with RA Procedures and Work Instructions.
• Ability to work with cross-functional teams.

This is not an exhaustive list of duties or functions

Expected Areas of Competence

• 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, 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

Education/Experience Requirements

• Bachelor’s degree in science / engineering is required; advanced degree is a plus
• English Proficiency is required; knowledge of additional EU languages is preferred.
• A minimum of 3-5 years of experience in Regulatory Affairs, Engineering, Quality, or related field required (a combination of higher education and less experience can be considered).
• Experience in a multicultural environment is preferred

Travel Requirements

• Up to 10%