Regulatory Affairs Specialists III

1. Files / maintains regulatory deliverables.

2. Participates as team member on all assigned new product introductions as applicable.

3. Communicates changes in existing products to applicable RA representatives for determination of the need for new/revised licenses or registrations.

4. Reviews and approves advertising and promotion material ensuring it is consistent with approved claims for regulated products.

5. Partners with applicable RA representative for countries with license expiration requirements, to establish plans and deliverables for timely submission for renewal of license.

6. Identifies any clinical data requirements for product licensing globally and ensure the requirements are documented in the compliance plan.

7. Completes specific country testing and work with Region RA, and arranges for test devices and support as needed.

8. Contributes to writing and editing technical documents

9. Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions

10. Understands and applies regulatory requirements and their impacts for submissions

11. Ensures compliance with pre- and post-market product approval requirements

12. Supports regulatory inspections as required.

13. Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.