Medical Device Regulatory Affairs
Medical Device Regulatory consultant
Our client is currently in the process of putting a team together to help with international submissions. Specifically, this consultant will be working to help submissions in the areas of Brazil and Japan. The experience that the client needs in someone’ s background is FDA and EU expertise, they believe this will translate well into the work that will be required.
Day to Day Responsibilities:
This consultant will be coming on site to work with their international submissions team. They will be identifying problems with their current strategy around submitting orthopedic products, determining the barriers and creating a strategy for overcoming them. This consultant should have knowledge of design control and how it effects a regulatory submission so they can create the best knowledge. This role is expected to become very technical and hand on. This consultant should also have experience working with design dossiers.
EU and FDA
Medical Devices Class II or Class III