QA / RA Specialist
A role combining Quality Assurance and Regulatory Affairs, more often found in the Medical Device sector
Main Responsibilities
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Apply technical solutions to problem solving
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Apply technical solutions to quality improvement projects
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Use technical writing skills to clearly describe technical information
Analyze customer complaints, identify trends and execute corrective actions
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Understand standards and their application to medical devices
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Planning, protocol generation, testing and report generation for medical devices
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Generation and maintenance of technical files for medical devices
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Review and update technical files in line with EU medical devices regulatory requirements
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The use of harmonised standards when compiling a technical file in compliance with the MDD
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Ensuring that records are filed in accordance with site procedures
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Supporting R&D
Skills / Experience
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Engineering / Science qualification
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3/4 years experience within R&D / QA/ RA/ Compliance or Validation function in a Medical Device Environment
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Excellent technical writing experience within a medical device environment
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2/3 years experience in Risk, Clinical and Biocompatibility an advantage
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Fluency in English