The ENOVIA 3DEXPERIENCE Regulatory Team Member (GLR) Role is a sophisticated, easy to use tool that helps produce submission-ready, quality content in a timely manner.
Regulatory Team Member manages global medical device market registrations, product identification processes and submissions throughout the product lifecycle. It evaluates and manages reportable safety events submissions to global health authorities.
Regulatory Team Member Benefits
Ensure Complete Control
Govern device registration process from planning, document gathering, compilation to submissions; tracking product registrations and managing interactions with the regulatory agencies; coordinating regulatory activities with a global plan and schedule for submission-ready deliverables in a timely manner.
Reduce Product Development Delays
Aggregate product Information on the 3DEXPERIENCE platform for single source of the truth as product change and evolve.
Improve Global Team Efficiency
Coordinate global activities for simply creating the submissions needed, managing dossiers, adding and reusing documents; regulatory teams are able to quickly identify all available, expected, in-process or missing submission documents by products, regions, or countries.
Speed Up Time to Market
Enterprise wide process for capturing, managing, approving and submitting device identification data. Govern Device Identification Records turning data into accessible product knowledge for submissions to FDA GUDID.
Reduce Issues Related to Adverse Event Tracking
Manage evaluation and reporting safety related adverse events to regulatory authorities from intake to decision trees and direct regulatory report generation to closure supporting eMDR submissions to the FDA.
Regulatory Team Member Highlights
- Complete control of regulatory communications staying on top of all regulatory activities, from communications to renewals.
- Accelerate time-to-market by streamlining and automating the complete regulatory submission and approval process (dossier assembly through end of life).
- Manage end-to-end DI (device identifier) submission and global regulatory submission tracking for market approval.
- Track reported adverse events and manage them from initial triage through reporting and case closure to meet the complex and varying requirements of global regulatory authorities.
Included 3DEXPERIENCE Apps
- Adverse Event Reporting.
- Device Identification.
- Market Registration.
- My Submissions.
ENOVIA PLM software is the product lifecycle management backbone of the Dassault Systèmes portfolio, used by many of the world's largest and most technically advanced manufacturing enterprises to streamline their organization.
3DEXPERIENCE Role FAQs
ENOVIA 3DEXERIENCE Advantage
Connect with other 3DEXERIENCE roles and take advantage of the virtual twin for the entire enterprise
Natively built for the cloud and also available on premises, ENOVIA spans the full spectrum from very small clients to customers with thousands of users.
This ‘infinite’ scalability is driving exponential adoption across all engagement models, letting clients plan and sustain their growth and address their evolving business needs.
Cloud is driving the ability to scale, drastically reducing the distance and time between technology decision and value realization, letting companies take continuous advantages of enhancements & scope extension every 8 weeks. Cloud adoption is now a reality for all sizes of clients.
Go beyond PLM
ENOVIA powered by the 3DEXPERIENCE platform goes beyond PLM, connecting people, ideas and data from across the value network into a single collaborative environment that transforms the way you do business.
The 3DEXPERIENCE platform provides a Safe, Social, Connected, Informed and Structured environment for team leaders, project managers and other professionals who want to manage data on the cloud and collaborate without constraints.
Safe: Customer controlled access. Transparent cloud backup. Encrypted communication protocols. Data always safe-no overwrite, no loss of data.
Social: Integrated structured and unstructured collaboration tools enabling social innovation. Collaborate on product design or engage with your stakeholders early in product development.
Connected: Every user always connected to a single, common database. Access data anywhere, anytime, on any device. Review and markup models.
Informed: Choose from the widget library, Create and share Dashboards. Get the latest information about your product development. Always have access to your latest data.
Structured: Zero overhead data management - store and manage data across collaborative spaces, share information in communities. Find indexed data faster by using tags, custom search, etc.
Interested in the Regulatory Team Member 3DEXPERIENCE Role?
Contact us and get your questions answered today.
US 440.257.7460 | UK 01926.333777