Regulatory Data Specialist
1 week ago
Company Overview
Genpact is a global professional services firm that delivers outcomes shaping the future. With over 125,000 people across 30+ countries, we are driven by our curiosity, agility, and desire to create lasting value for clients. We serve leading enterprises, including Fortune Global 500 companies, with deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.
About the Role
We are inviting applications for the role of Regulatory Data Specialist, with expertise in Medical Device and Master Data Management for Regulatory processes and activities. In this position, you will work on custom deliverables involving analysis of requested data, providing feedback and recommendations to clients, creating and updating files and systems for data delivery.
Key Responsibilities
- Create and analyze reports for mainframe/Linux, Excel, and maps for sample availability, contiguity, sales, and release in each geography.
- Collect, aggregate, compare, and explore data based on functions and region-specific guidelines.
- Collaborate with team members to collect process and analyze data.
- Initiate data updates in PIM.
- Suggest process improvements and provide support with automation.
- Act as subject matter 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 clients.
- Re-evaluate entire requests based on changes.
- Create, update files and systems for data delivery.
- Create historical weekly data files based on client type and data.
- Multitask between different streams of work and systems simultaneously.
- Create rules for processing and link various inputs according to requirements.
- Lead daily assigned activities and collection of data.
- Coordinate with Central teams for priorities and backlogs.
- Ensure quality of data.
- Develop a strong network of data-related contacts.
- Responsible for implementing a Global UDI data clean-up strategy.
- Operational knowledge of 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.
What We Seek in You
Minimum Qualifications/Skills:
- Graduate (Any Bachelor's Degree)
- Relevant years of experience in healthcare or life sciences industry
- Intermediate 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 tools, and Processes
- Understanding of 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 ServiceNow, management tools, and data analytics tools
- Ability to prioritize and organize own workload
- Strong aptitude for learning
- Effective time management to meet SLA & client deliverables
Estimated Salary: $65,000 - $90,000 per annum
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