Regulatory Affairs Submissions Specialist (REMOTE)

Los Angeles, CA

Industry: Regulatory & Scientific Job Number: 147343


Regulatory Affairs Submissions Specialist (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 work with the team on multiple 510k submissions to the EU market.


Day to Day Responsibilities:

This consultant will be responsible for collaborating with the team on authoring up to ten 510k submissions. They will be contributing in the authoring of 510k’ s for class II dental devices and prior experience with writing these submissions is a requirement. The client is looking for someone with recent submissions experience to hit the ground running as they have a very aggressive timeline. Basic templates will be provided and they consultant will be working on a non-electronic format for the submission. 

Required Skills:

510k Submissions Experience

Class 2 dental Device submission experience


Job Type: Contract 

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