Job Description
This will be a four month contract that will require you to be onsite in Ireland 2/3 times a month. Key Responsibilities Take point on line-by-line assessment of standards requirements vs the product requirements and applicable evidence for client infusion products Responsible for assigning actions, reviewing compliance tools for completeness and appropriateness of referenced information Documenting the status at a regular cadence of the compliance assessment and compliance actions Design, lead and/or provide direction for IEC 60601 compliance testing Perform gap analysis in areas such as quality systems and risk management Participate in risk management activities Assess or create requirements traceability matrices Support or recommend remediation activities based on a strong background in quality management systems and regulatory compliance Create, evaluate, maintain and/or update the DHF and/or applicable portions of regulatory submissions Recommend remediation activities Key Requirements Electromechanical Medical Device background (infusion pumps is advantageous) Experience with 60601, 62304, 62366, 62133, 14971 (phone number removed)-24 experience is advantageous Experience with MDR Experience coordinating and implementing product testing at external test laboratories Experience with identifying requirements for compliance test plan Background in Electrical/Electronic or Mechanical preferred