||1. Monitor and provide management with impact of changes in the Regulatory environment.
2. Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management.
3. Document, consolidate and maintain oral and written communication with FDA, notified bodies, and clinical investigators.
4. File annual notification, annual establishment, state, federal registrations, product changes of FDA, Health Canada, EU, notified bodies, and other regulatory agencies throughout the world.
5. Support Design Control process.
6. Provide Regulatory perspective and requirements in cross-functional project teams.
7. Develop Regulatory Strategies for new or modified products.
8. Prepare Rational to File documentation for modifications to devices when appropriate.
9. Participate in FDA Inspections.
10. Author and/or review regulatory procedures and update as necessary.
11. Execute and manage submissions such as US FDA Section 510(k) Notifications, Pre-market Approval (PMA) Applications and Supplements, EU IVDD Technical Documentation, and global product registrations.
12. Participate and conduct Internal Audits.
13. Participate in third party audits of the Quality Management System and assist in the development of responses to support audit corrections and rebuttals.
14. Review change control documents and ascertain Regulatory impact for external and internal documents.
15. Coordinate the notarization and legalization of regulatory documents.
16. Maintain external references and lists of national and international regulations, standards and FDA guidance documents that affect the products and operations.
17. Assist in development/maintenance of regulatory files, records and reporting systems of systematic retrieval of information.