Lead Associate -Regulatory in medical Device domain - associated Master Data Management for Regulatory processes and activities.

Lead Associate -Regulatory in medical Device domain - associated Master Data Management for Regulatory processes and activities.-ANA015287

Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose – the relentless pursuit of a world that works better for people – we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.

Inviting applications for the role of Lead Associate and Lead consultant with expertise in Regulatory in medical Device domain and associated  Master Data Management for Regulatory processes and activities.

In this role, we are looking for a qualified professional who can provide guidance to the team with subject matter expertise in Regulatory and Master data management.  Reports typically comprising of first line managers and supervisors.

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

Qualifications we seek in you!
Minimum Qualifications/Skills
•    Bachelor's degree in science and health related field
•    Relevant years of experience Regulatory affairs operations, Compliance, IT or quality
•    Strong analytical skills and problem-solving skills 
•    Proven work experience as a Sr Team member, Subject matter Expert or Associate business analyst
•    A background in the Life sciences industry (Pharmaceutical, Medical Device, or Bio-Tech) 
•    Effective communicate in writing and verbally to client.
•    Prior experience in PIM system, MDM systems, Regulatory tool and Processes
•    Can understand Medical Device details and business context for data

Preferred Qualifications/Skills
•    Overall candidate should have problem solving, macro-level research and analytics approach and good in numbers.
•    Good people and customer handling skills
•    Effective communication and interpersonal skill
•    Lean Six Sigma Certification (Green Belt) preferred.

Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. Get to know us at www.genpact.com and on X, Facebook, LinkedIn, and YouTube.
Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.

 

Job

 Lead Associate

Primary Location

 India-Bangalore

Schedule

 Full-time

Education Level

 Bachelor's / Graduation / Equivalent

Job Posting

 Nov 14, 2024, 8:51:29 AM

Unposting Date

 OngoingMaster Skills List OperationsJob Category Full Time