Associate - Regulatory knowledge in domain of Medical Device - associated Master Data Management for Regulatory processes and activities.
Genpact
5 - 10 years
Bengaluru
Posted: 11/20/2024
Job Description
Responsibilities
Create and analyze Mainframe/Linux, excel and maps reports for each geography for sample availability, contiguity, sales, release
Collects, aggregate, compare and explores data based on functions and region-specific guidelines.
Collaborate with team members to collect process and analyze data.
Initiates data update in PIM
Suggests Process improvements and provide support with automation
Acts as subject maer expert for product information/data governance within a Business Unit
Identify data holes and issues with sample, contiguity, sales, release and provide recommendations and feedback to the clients
Re-evaluate the entire request based on changes
Create, update files and systems for data delivery
Create historical weekly data files based on client, type of data
Multitask between different streams of work and systems at the same time
Create rules for processing and link various inputs as per requirements
Leads daily assigned activities and collection of data
Coordinates with Central team for priorities, back log
Ensure quality of data
Develop strong network of data related contacts
Responsible for Implementation Global UDI data clean up strategy.
Operational knowledge of the European Medical Device Regulation (EU MDR) EUDAMED, US FDA, GUDID, and /or Global UDI Regulations, ISO13485-Quality Management System
Operational knowledge of country specific UDI requirements, artwork, medical device attributes and terminology
About Company
Genpact is a global professional services firm delivering digital transformation by putting digital and data to work to create competitive advantage.
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