Associate - Regulatory knowledge in domain of Medical Device - associated Master Data Management for Regulatory processes and activities.

Associate - Regulatory knowledge in domain of Medical Device - associated Master Data Management for Regulatory processes and activities.-ANA015283

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 Associate/Senior Process Associate, with expertise in Regulatory knowledge in domain of Medical Device and associated Master Data Management for Regulatory processes and activities.
In this role, you will be working on Custom deliverables that involves analysis of the data requested, provide feedback/recommendation to client, create, and update files and systems for data delivery.
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 ma􀆩er 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

Qualifications we seek in you!
Minimum Qualifications / Skills
•    Graduate (Any Bachelor's Degree)
•    Relevant years of experience in healthcare or life sciences industry
•    Intermediates excel knowledge
•    Good problem solving and data analysis skills
•    Good communication skills (written and verbal)
•    Good attention to detail
•    Ability to multitask
•    Prior experience in PIM system, MDM systems, Regulatory tool and Processes
•    Can understand Medical Device details and business context for data

Preferred Qualifications/ Skills 
•    Flexibility to adapt
•    Experience in writing SQL, Data wrangling, Data profiling and data validation, Data Analyst, Data architect
•    Experience with service now, management tools and data analytics tool
•    Ability to prioritize and organize own workload
•    Strong aptitude for learning     
•    Manage time effectively to meet SLA & client deliverables

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. For more information, visit www.genpact.com. Follow us on Twitter, 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

 Associate

Primary Location

 India-Bangalore

Schedule

 Full-time

Education Level

 Bachelor's / Graduation / Equivalent

Job Posting

 Nov 14, 2024, 8:24:08 AM

Unposting Date

 OngoingMaster Skills List OperationsJob Category Full Time