This is Regulatory Affairs Senior Specialist position is with a mid-sized device company based in northern MA. This company is dedicated to providing a broad array of light-based aesthetic and medical treatment systems to patients in need. They are expanding their regulatory team, so it is a very exciting time to join!
- Generate and manage the technical files for class I and II devices that are in compliance with the EU MDD
- Provide regulatory strategy and guidance to product development teams, to ensure accurate and timely submissions
- Assist in the submissions for countries with complex requirements
- Review changes made to existing products and update requirements for regulatory submissions
- Knowledge of EU Medical Device Regulation