Lead consultant - Regulatory in medical Device domain - Associated Master Data Management - Regulatory processes and activities.
Genpact
5 - 10 years
Bengaluru
Posted: 11/20/2024
Job Description
Responsibilities
System Management
Review and generates business-centric application metrics periodically
Develop, implement and coordinate regional training and communication on subscriptions, tools, and processes as appropriate
Responsible for supporting the research/analysis product master data issues and liaising with business and technical teams to improve data quality through process improvements
Support Central RA team that drives the strategy and execution for shared services support
Monitors and reports on performance within area of responsibility according to standards
Able to assess processes to recommend and drive to efficient future state processes, including gaining agreement from key stakeholders
Support updates of communications, including metrics, newsletters, and town halls
Execute day to day Master data management activities
Act as the SME in the Master data management activities
Ensure data quality for deliverable is met and all metrics adhered
Ensure master data integrity between modules & systems at efficient quality and accuracy, Coordinate, Analyse and facilitate resolution of issues
Perform Regression Testing or Change Request Testing, Generate & Analyse regular reports: statistics of MD Maintenance (e.g. no. of errors, lead time violation, etc) & Data Quality Key performance indicators.
Support the business unit team for expediting the master-data creation of fast-track projects.
Ensure SLA (Service Level Agreements) for lead times and data quality are fully met
Highlight lesson learned on frequent issues, Support regular Master Data Check & Audit Trail validation
Creation, Maintenance and completeness check for all Master Data based on various document sources in co-ordination with different teams and verticals
Guiding and leading cross-functional teams in implementation of data
Analysing and reporting metrics of master data to reduce customer data issues and improved customer data quality in order to ensure that teams follow and support
Good analytical skills, propose process improvement plans
Knowledge on Data management, Regulatory tools, PIM and workflow systems
Fully responsible for all Regulatory master data governance, processes/tasks for product lifecycle change control within PIM system
Support and lead Regional Regulatory communication planning and implementation across multi- functional verticals
Act as Business test lead, develop and implement test scripts
Author/review/approve business application documents
Operational Knowledge of the European Medical Device Regulation (EU MDR) EUDAMED, US FDA, GUDID, and /or Global UDI Regulations, ISO13485-Quality Management System
Assists in application test planning and execution and reviews of software development lifecycle documentation
Operational Knowledge of country specific UDI requirements, artwork, medical device attributes and terminology, Implementation Global UDI data clean up strategy
Regulatory compliance
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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