Sr Regulatory Specialist- Medical Device- Remote Opportunity
Location: Princeton, New Jersey, United States
Sectors: Regulatory Affairs (RA)
Job Type: Contract
Sr Regulatory Affairs Specialist- Full Remote Opportunity
Hours: Monday-Friday 8am-5pm
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Supports manufacturing/operations day to day activities for change control.
- Provides consultation/advice to regulatory specialist for change control and product development.
- Provides regulatory direction/interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams.
- Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
- Handles regulatory activities involved in documentation, labeling, field support.
- Applies regulatory and technical knowledge to a wide variety of complex work assignments.
- Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
- Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.
- Knowledge of US regulations and standards affecting IVDs
- Experience as contributing author for US submissions
- Full Benefits- Health, Dental & Vision