About the job
The Regulatory specialist collaborates closely with the Development, Quality and Clinical teams for the preparation and submission of Regulatory Technical documentation (with focus on EU and US authorities).
- Hands-on support with the Development, Quality and Clinical teams to prepare technical documentation in compliance with country specific regulations (EU and US).
- Maintain Technical files for submission (CE and FDA).
- Maintain applicable standards list and traceability between technical documents and applicable standards.
- Manage Packaging and Labeling requirements.
- Perform routine regulatory monitoring, and coordinate with Subject matter experts the impact analysis of new/updated standards
- Perform regulatory impact analysis on design change requests.