Medical Device Regulatory Affairs

Industry: Regulatory & Scientific Job Number: 146763

Medical Device Regulatory Affairs Consultant

Project Description:                                                     

Our client is a large medical device company and is in need of a regulatory affairs consultant to help assist the supporting business.  Currently the client is pulling full time employees off of day to day activities and placing them on their EU MDR project.  They need someone to come on board and help sustain the business.  This person will be responsible for US and EU submissions.  

 

Day to Day Responsibilities:

This consultant will be helping the client with their day to day activities.  The consultant will primarily be working on maintaining products that are already on the market and support US and EU submissions.  The majority of the products are class II devices, therefore most of the work will be revolving around 510K’ s.  There are some products that are classified as Class III, so experience in that area is a plus but not necessary.  This person will also be working on maintaining technical files for the EU market.

Required Skills:

Regulatory Affairs

Submissions

EU and USA

Job Type: Contract 

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