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Medical Device Regulation Implementation Consultant

An international company is looking for a QA/RA consultant. As a QA/RA consultant you will have the following responsibilities:

  • Perform MDR gap analysis for the legal manufacturer ;
  • Create required SOPs, quality agreements and other required documents to support MDR implementation ;
  • Support in MDR training ;
  • Support in preparation and execution of MDR audits ;
  • Review and update ISO certification strategy and SOPs;
  • Interact with all levels of organisation ;
  • Evaluate audit responses for adequacy ;
  • Resolve complex issues and escalate concerns through business and Quality Compliance Management ;
  • Participate in other projects as needed.

What are they looking for in a QA/RA consultant?

  • Minimum 5 year's experience in Quality, Regulatory, Compliance, Manufacturing
  • Bachelor's degree in Science or Engineering discipline
  • Experience in medical device
  • Knowledge of EU MDD and ISO 13485
  • Experience in SOP/manual/guidelines writing
  • Good communication skills
  • Fluent in English

The company can provide an interesting career in a dynamic environment with lots or learning and growth opportunities.

This is a job description in short, if you want more information you can send me an email or call me at 02/610.59.59.