Regulatory Affairs

Draft and prepare product technical documentation for CE marking activities and notified body interaction to accomplish EU MDR product authorization - Understand and interpret EU and US medical device regulatory requirements - Develop regulatory strategies and plans for submissions for international product registrations - Draft and prepare 510(k) submissions and lead process through clearance/approval - Support engagements with EU, US, and global regulatory agencies as required to confirm acceptability of regulatory strategy - Review product labels, labeling, and promotional materials. - Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other teams

You will have the opportunity to contribute to the advances in technology and medicine to develop new devices and equipment that improve human health.

If you have a young and dynamic profile, are ambitious and eager to embark on a new adventure with a company in the process of expansion where growth opportunities are many, sign up for this offer.

**We offer**:
The opportunity to work in a dynamic and innovative startup environment.
Continuous learning and professional development.
Collaboration with a talented and passionate team.

Possibility of full remote work
- Draft and prepare product technical documentation for CE marking activities and notified body interaction to accomplish EU MDR product authorization
- Understand and interpret EU and US medical device regulatory requirements
- Develop regulatory strategies and plans for submissions for...