Sr. Regulatory Affairs Specialist

Edison, NJ

Job ID: 131333 Industry: Regulatory & Scientific

Sr. Regulatory Affairs Specialist

 

Background: The client is a large medical device company that has some gaps in their Regulatory documents. They need a Sr. Regulatory Specialist to come on and participate in the updating of these documents so that they are in compliance with FDA regulations.   A concentration on 510K submissions and experience updating Regulatory documents is also expected from this consultant.

Project: The consultant for this role will be onsite fulltime to help with the updating of documents. They will come on and work independently to complete the updates of 510K’ s in compliance with FDA regulations. This person is expected to have a concrete understanding of FDA regulations, be able to identify gaps in Regulatory documents, and work autonomously when updating and correcting the Regulatory documents.

Required:

Regulatory Affairs

Medical Device

510K

Job Type: Contract 

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