Medical Device Regulatory Affairs Consultant

Edison, NJ

Industry: Regulatory & Scientific Job Number: 133238

 

           

Medical Device Regulatory Affairs Consultant

Project Description:                                                     

Our client is a large medical device company and is looking to build a team of people to help with the remediation efforts required to update their 510k’ s and PMA’ s. 

 

Day to Day Responsibilities:

This consultant will be responsible for updating 510K’ s and PMA’ s.  This person must be a SME in submission for the FDA and have a working knowledge of what is needed within a technical file.  In addition to working with 510k’ s and PMAs, this person will be working with change notices for the EU, updating some technical files and PMA supplements.  This person is expected to work with little to no direction and provide both gap assessment advice and hands on execution work. 

Required Skills:

Regulatory Affairs

510K

PMA

Job Type: Contract 

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