Regulatory Affairs Project Manager

Los Angeles, CA

Job ID: 127790 Industry: CLINICAL

           

Remote Medical Device Regulatory Affairs

Project Description:                                                     

Our client is currently in need of a regulatory affairs consultant to come on site and help with a technical file gap assessment.  The client recently purchased a smaller organization and need someone to review their regulatory documents to ensure that they are meeting current regulations for the FDA and EU.  The devices they will be reviewing are classified as Class IIA. 

 

Day to Day Responsibilities:

This role is intended for someone who has conducted regulatory technical file gap assessments in the past.  The consultant will be reviewing the technical files, identify where there are gaps and develop a remediation plan to fill any gaps that are identified.  This role will require both hands on gap assessment and also the ability to drive the remediation project after the gaps are identified. The client is a Class IIA medical device company and experience within that realm is a necessity.  Any experience working with contact lenses care products is a plus.

Required Skills:

Regulatory Affairs

Technical Files gap assessments

Medical Devices Class IIA

Job Type: Contract

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