Quality Assurance / Regulatory Affairs Officer
compliance with ISO 13485, UK MDR 2002, MDR 2017/745, MDD 93/42/EEC, MDSAP,
QMS CAPA ERP LSAS QRM GMP & GDPR ISO14971 Microsoft Dynamics AX
Established medical instrumentation design and manufacturer are looking to recruit a Quality Assurance / Regulatory Affairs Officer to support all aspects of the quality management systems for all the Harlow Essex CM20 based Group's Companies.
To provides technical support, guidance and discipline for medical device manufacturing, engineering, and distribution, in the areas of Quality Assurance, regulatory compliance, and quality systems requirements. Use of root cause analysis to address problems and identify trends. To conduct Quality Audits across all organisations.
Key tasks will include ensuring that the Group maintain regulatory approvals, quality auditing, calibration administration, CAPA administration, supporting and maintaining technical files, risk and CER file management and updates, supporting the QA Admin team, data creation for Quality Management Reviews, liaising with MHRA and other regulatory bodies as required forfilling QA/RA Team Leader responsibility to maintain QMS compliance including procedure updates.
A comprehensive knowledge of medical device quality standards and regulatory requirements would be highly beneficial, however alternative experience in quality standards would also be considered.
You will need to have the ability to analyse and implement improvements. Good analytical IT skills are needed and experience of Microsoft Dynamics AX would be beneficial.
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