Regulatory Affairs Submissions Manager (REMOTE)

Los Angeles, CA

Industry: Regulatory & Scientific Job Number: 147342


Regulatory Affairs Submissions Manager (REMOTE)

Project Description:                                                     

Our client is a small medical device organization that specializes in dental products. They will re-registering their products in the international market. They will be looking for a senior level resource with prior dental device experience to come on and lead multiple 510k submissions to the EU market.


Day to Day Responsibilities:

This consultant will be responsible for managing up to ten 510k submissions. They will be leading the authoring of 510k’ s for class II dental devices and prior experience with writing these submissions is a requirement. As well this individual will be leading meetings both internally and with notified bodies to explain the progression of the deliverables. This individual should be comfortable presenting the submissions to the notified body and addressing all possible concerns. Basic templates will be provided and they consultant will be working on a non-electronic format for the submission. This consultant must be comfortable working in a fast paced environment.

Required Skills:

510k Submissions Experience

Class 2 dental Device submission experience

Job Type: Contract 

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