E-commerce & Marketing Collective.
Senior Regulatory Affairs Operation Specialist, Data Integrity
Location
United States
Posted
11 days ago
Salary
Not specified
Job Description
Job Requirements
- Bachelor's of Science degree in Regulatory Affairs or relevant scientific or life science field and two (2) years of experience in Regulatory Operations
- Will accept a Master’s Degree in lieu of the Bachelor’s degree and two (2) years of Regulatory Operations experience
- Additional experience must include managing and publishing regulatory submissions for investigational or marketed products
- Configuration and vault loader functionality in Veeva Vault RIM
- Industry standards, regulations, guidelines related to regulatory submissions for medical devices
- Experience with multiple cloud-based RIMS systems (such as Veeva) in Regulatory and Regulatory Content Management
Benefits
- Support the governance and review of Regulatory Affairs data integrity
- Support digital transformation projects
- Assist with on-boarding and integration of a new regulatory information management system
- Support the implementation, launch and maintenance of new systems and processes
- Work across multiple functional projects to understand data usage and implications for data integrity
- Identify various sources of data and oversee the extractions of source data
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