YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Data Management Specialist Global Regulatory Operational Excellence are to:

• Registers all Bayer Radiology facilities accordingly with US FDA and Health Canada.

• Maintains device listing information in US FDA FURLS (FDA Unified Registration and Listing System) database.

• Executes and maintains data management processes, communication and compliance.

• Maintains and monitors Radiology Global Regulatory Affairs KPIs.

• Helps confirm UDI requirements, develops and assesses processes, and ensures systems/data managed appropriately for country specific device UDIs.

• Participates in the assessment, procurement and/or implementation (including training) of Bayer Regulatory Radiology IT systems (e.g. Labeling, Regulatory document management, health authority communication, submission tracking systems etc.).

• Manage Bayer Regulatory Radiology IT systems and tools and partner with internal Bayer IT resources and external vendors, as needed, to manage system upgrades, configuration updates, and all other change management activity.
   
• Support Regulatory Operational Excellence programs/projects as subject matter expert (SME) on regulatory systems and relevant data analytics through the preparation, analysis, and maintenance of operational metrics/KPIs.

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Ph.D., M.D., P.Eng. or PharmD with no Regulatory experience required; or Master's with a minimum of 2 years of Regulatory experience; or a Bachelor's degree with a minimum of 6 years' of Regulatory experience.
   
• Working understanding of device regulations.
   
• Substantial and successful experience with multitasking.
   
• Ability to manage and effectively analyze large quantities of data.
   
• Ability to communicate effectively in English both verbally and in writing.
   
• Business Computer Skills and Business Applications.
   
• Team and customer orientation.
   
• Previous experience with database management is strongly preferred.
   
• Must be motivated to work independently as well as with cross functional team
   
• The successful candidate will display:
   
  • Results orientation.
  • Attention to detail and strong analytical thinking.
  • Ability to collaborate