Regulatory Compliance Specialist
North Chicago, IL 60064
- Work with US, ex-US & CMC areas to establish data categorization and provide analysis of data in system.
- Responsible for reviewing & maintaining registration compliance information in accordance with change control processes.
- Receive and enter registration compliance data into system.
- Responsible for maintaining keyword lists associated with the data entry requirements.
- Work with global regulatory affairs area representatives & affiliates to build relationship and common understanding of the requirements for Registration Compliance.
- Assimilate disparate information from multiple resources, analyze for trends, adjust and raw inferences.
- Track metrics associates with data capture/entry effort.
- Execute business processes for Registration Compliance.
- Review data & determine if new categories/classifications are required.
- 3+ years in a related area including manufacturing, regulatory affairs, quality in the pharmaceutical, medical device, or other healthcare industry.
- Experience/understanding/use of software tools.
- Demonstrated analytical capabilities.
For more information, please contact A-Line Staffing at 877-782-3334.