Regulatory Affairs Officer

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What you need to know 

You will work as a Regulatory Affair Officer for our client, an established manufacturing company in the Southeast.

As the Regulatory Affair Officer, you will be responsible for regulatory support for operations, product development and quality to ensure that the product follows all internal and external regulatory requirements

This is a permanent position.

Your new job 

Key duties & responsibilities: 

  • Develops, documents and implements a regulatory submissions plan around product development/line extension goals.
  • Prepare U.S. FDA submissions as required and per applicable SOPs.
  • Prepare and updates European and international technical files/dossiers/registrations as required and per applicable SOPs.
  • Review Engineering Change Orders, Design Change Notices and other deviations for compliance with FDA, European and international regulations and standards.
  • Ensure adequate documentation compliance to FDA, European and international regulations and standards.
  • Develop working relationships with key personnel/representatives of the U.S. FDA Offices of Device Evaluation and Compliance and Notified Body.
  • Prepare and present project updates and technical discussions.

What are we looking for? 

  • The successful candidate will be educated to third level degree preferably in science or business.
  • You will have 3+ RA related experience.
  • You will have knowledge of U.S. and/or European regulations and standards covering medical devices
  • You will be IT literate and adapt to new systems easily.

Apply for this job now by sending your CV to John.

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Recruitment Consultant: John O' Donnell

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