Regulatory Information Management Specialist
hace 2 semanas
About Zimmer Biomet
At Zimmer Biomet, we are dedicated to advancing innovation and fulfilling our mission. As a leading global medical technology company for nearly a century, our products and technologies enhance patient mobility every 8 seconds.
Our Commitment
As a member of the Zimmer Biomet team, you will be part of our dedication to providing mobility and renewed life to individuals worldwide. We prioritize development opportunities, robust employee resource groups (ERGs), a flexible work environment, competitive total rewards tailored to specific locations, wellness incentives, and a culture that recognizes and rewards performance. We strive to create an atmosphere where every team member feels inspired, valued, and has a strong sense of belonging.
Role Overview
The Regulatory Affairs (RA) Specialist for the systems team plays a crucial role in supporting the maintenance and implementation of RA systems, particularly focusing on the Regulatory Information Management System (RIMS) and Regulatory Distribution Controls through SAP Global Trade Services (GTS) software. This position requires expertise in data analysis and data mining.
Key Responsibilities
- Assist Business Unit RA activities, including publishing, filing, establishment registrations, and product listings with regulatory authorities.
- Create and maintain regulatory affairs registrations and licenses within RIMS/GTS distribution control systems to support global product distribution regulatory controls.
- Manage the release and oversight of RA blocks.
- Generate and communicate GTS/distribution control reports promptly.
- Maintain records (objective evidence) according to established procedures.
- Track GTS/distribution control blocks effectively.
- Conduct User Acceptance Testing (UAT) as required for RIMS and GTS.
- Collaborate closely with global RA teams and customer service to address issues related to GTS/distribution control blocks and maintain objective evidence.
- Perform gap analysis on existing license master data and develop summaries using advanced Excel and other data analysis tools.
- Upload and maintain RA data in RIMS and GTS systems using automated upload tools, troubleshooting data errors as necessary.
- Apply technical expertise in data mining and modeling tools to provide insights into distribution control data for RA and recommend enhancements to existing processes.
- Understand software validation and testing protocols.
- Comprehend medical device regulations and their applications.
- Understand distribution, logistics, and order flow from various Enterprise Resource Planning (ERP) Systems to GTS.
- Conduct training for team members on tools and techniques for maintaining data integrity.
- Support the development of training materials and work instructions.
Qualifications
- Preferred experience with global regulatory systems.
- Experience with data mining tools and advanced Excel skills is preferred.
- Strong writing, communication, and interpersonal skills.
- Excellent problem-solving and analytical abilities.
- Ability to learn and apply regulations relevant to medical devices, biologics, drugs, and combination products.
- Knowledge of regulations pertinent to medical devices, biologics, drugs, and combination products in regions such as the EU, EMEA, APAC, LATAM, or the US.
- Attention to detail and the ability to work in an organized and consistent manner.
- Proficiency in software such as SAP modules, SAP GTS, ERP systems, Microsoft Office Suite, Adobe Professional, and Excel for data analytics.
Educational Background
- A Bachelor's degree (or non-US equivalent) is required; a concentration in life sciences, technical/engineering, or a related field is preferred.
- Proficiency in English is required (C1 level); proficiency in Portuguese is preferred.
- A minimum of 3-5 years of experience in Regulatory Affairs, Engineering, Quality, or a related field is required.
Travel Expectations
We are an Equal Opportunity Employer (EOE/M/F/Vet/Disability).
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