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Senior Regulatory Affairs Specialist

Hours : Full Time
Travel : No
Relocation : No

Job Description :

Our client’s contribution to healthcare is offering a range of diagnostic solutions, clinical data management tools and process management expertise.  Their goal is to provide solutions improving healthcare around the globe.  If you are looking for an opportunity to contribute your skills and knowledge our client has a 6 month contract position available – Senior Regulatory Affairs Specialist.


 


In this role you will:



  • Plans, coordinates, facilitates, and reports on company regulatory programs

  • Evaluate, coordinate, prepare and implement pre-market Regulatory Affairs activities

  • Administration and setup of template FDA and agency submissions for IVD projects

  • Planning and implementing pre-market registration, reporting and compliance activities in accordance with the development center business plans

  • Implementing global regulatory compliance programs for product corrective action and/or adverse event reporting

  • Preparing premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc.) for US and other governments

  • Provide assistance to technical departments, manufacturing business centers and suppliers in the creation and structuring of clinical data for pre-market notifications


 
Required Qualifications :


  • Bachelor’s Degree in field with 5+ years exp

  • OR Master’s Degree in field with3+ years exp

  • Medical Technologist background and IVD experience – Desired!

  • Demonstrated knowledge and understanding of regulations and guidelines governing the areas of medical devices and in vitro diagnostics

  • Previous experience authoring premarket submissions, including 510(k)s and PMA’s to the U.S. FDA

  • Ability to create Technical Files in compliance with IVDD and IVDR

  • Previous experience working with international colleagues on establishing design dossiers for their intended market

  • Previous experience in developing effective regulatory strategies and applying regulations to premarket strategies


 


 
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