Job Description: Summary
As BD's Corporate Regulatory Operations (Reg Ops) Data Specialist, this position supports one of BD's most complex and global initiatives which has C-Suite impact and visibility. The individual will be responsible for managing the data derived from various source systems, standardizing data and translating data in preparation for UDI submission across multiple countries and system platforms.
The Regulatory Operations Data Specialist would report to the Associate Director of Regulatory Operations and would require an advanced capability to prioritize, communicate, and follow-up on tasks across various projects within the department. The Reg Ops Data Specialist should exhibit experience working with data and databases including the various phases of data collection, data maintenance, and converting the data into business intelligence. This position will need to take complex data issues raised by Business Units and translate them into easy to understand information with options and recommendations on how to best support business unit users in a timely fashion.
This position requires an individual that can map out the most complex processes, has a passion for big data, and enjoys applying emerging technologies to improve business operations. A demonstrated ability to engage users of our systems globally, at the "how to" level, and to help them get the most value from our platforms is critical.
This position would be based in BD's Corporate Headquarters in Franklin Lakes, New Jersey and would require domestic and international travel on occasion.
Essential Job Responsibilities:
Responsible for executing Regulatory product master data governance processes/tasks related to product life cycle change control within the UDI ecosystem.
Responsible for maintaining databases
Responsible for extracting and maintaining massive data loads from ERP Systems and mapping
Responsible for supporting the research/analysis product master data issues and liaising with business and technical teams to improve data quality through sustainable process improvements.
Responsible for following up with BUs on data requests needed to support reporting needs
Responsible for planning and consolidating content for key stakeholder meetings and workshops
Responsible for triaging data issues with various business functions
Bachelor's degree; any discipline
3 years working experience in the in the life sciences industry (Medical Device, Pharma, Biotech)
2 years working with master data, supporting data maintenance, compiling data insights/reports
Detail-oriented and analytical with demonstrated ability to extract insight from data
Very strong Microsoft Office skills. Specifically, Excel formulas, data tables and analysis tools.
Preffered: 2 years working experience in Regulatory Affairs/Operations, Compliance, or Quality
Preferred: Experience maintaining data quality in a Product Information Management (PIM) system or Master Data Management (MDM) system
Preferred: Experience with database architecture and SQL
Preferred: Exposure to Oracle Product Hub Cloud and/or SAP/JDE Material Master
Preferred: Experience with Tableau, PowerBI, or Qlik reporting tool skills/certifications
Optional: Regulatory Affairs Certification (RAC)
Optional: Knowledge of the Medical Device Regulation (EU MDR) EUDAMED or U.S. FDA GUDID or UDI or Global Data Synchronization Network (GDSN)
Optional: Microsoft Teams and SharePoint experience
Primary Work Location
USA NJ - Franklin Lakes
BD (Becton, Dickinson And Company)