Data Management Specialist Global Regulatory Operational Excellence
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
- 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:
- 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
- Substantial and successful experience
- 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
- Team and customer
- 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
- Results orientation.
- Attention to detail and strong analytical thinking.
- Ability to collaborate
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
Functional Area: [sap_fa_32]
Entry Level: 5