Medical Regulatory Affairs Specialist
ALKU
PA
hace 39 días

Project Description :

Our client is a large medical device company and is need of a consultant to come on board and help with project work while some of their full time staff is being pulled onto a separate project.

This work will be primarily supporting the US, EU and Canadian markets.

Day to Day Responsibilities :

This consultant will be helping the client with their regulatory activities while they are light on staff. The consultant will be expected to submit 510K’ s to the FDA along with submissions to the EU & Canada.

The projects will be working with both new product development as well as sustaining of existing products. They will be responsible for the submissions as well as the international registration and labeling aspects that come with it.

This person will be responsible for conveying the status of the project to the client and keep progress moving forward.

Required Skills : Regulatory Affairs

International Registrations

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